Document ID: FDA-2017-N-3203-0001
Agency: fda
Document Type: Notice
Title: Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New
Drug Applications and 161 Abbreviated New Drug Applications
Posted Date: 2017-06-21T04:00Z

[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28322-28329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12908]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3203]

Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 
New Drug Applications and 161 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 121 new drug applications (NDAs) and 161 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the Agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: The withdrawal is effective on July 21, 2017.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)). 
The applicants have also, by their requests, waived their opportunity 
for a hearing. Withdrawal of approval of an application or abbreviated 
application under Sec.  314.150(c) is without prejudice to refiling.

[[Page 28323]]

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 005897.............  Folvite (folic acid)     Wyeth Pharmaceuticals
                          Injection, 5             Inc., Subsidiary of
                          milligrams (mg)/         Pfizer Inc., P.O. Box
                          milliliter (mL).         8299, Philadelphia,
                                                   PA 19101-8299.
NDA 006343.............  Wydase (hyaluronidase)   Baxter Healthcare
                          Injection USP.           Corp., 32650 N.
                                                   Wilson Rd., Round
                                                   Lake, IL 60073.
NDA 007390.............  Banthine (methantheline  Shire Development
                          bromide) Tablets, 50     Inc., 725
                          mg.                      Chesterbrook Blvd.,
                                                   Wayne, PA 19087.
NDA 008126.............  Cortisone Acetate        Pharmacia & Upjohn
                          (cortisone acetate)      Co., Subsidiary of
                          Tablets, 5 mg, 10 mg,    Pfizer Inc., 235 East
                          and 25 mg; and           42nd St., New York,
                          Injection, 25 mg/mL.     NY 10017.
NDA 008732.............  Pro-Banthine             Shire Development Inc.
                          (propantheline
                          bromide) Tablets, 7.5
                          mg and 15 mg.
NDA 011683.............  Thiotepa for Injection,  Immunex Corp.,
                          15 mg/vial.              Subsidiary of Amgen,
                                                   1 Amgen Center Dr.,
                                                   MS 17 1B, Thousand
                                                   Oaks, CA 91320-1799.
NDA 011836.............  Presamine (imipramine    Sanofi-Aventis U.S.
                          hydrochloride (HCl))     LLC, 55 Corporate
                          Tablets USP.             Dr., Bridgewater, NJ
                                                   08807.
NDA 012003.............  Akineton (biperiden      AbbVie Inc., 1 N.
                          HCl) Tablets, 2 mg.      Waukegan Rd., Dept.
                                                   PA77/Bldg. AP30-1,
                                                   North Chicago, IL
                                                   60064.
NDA 012421.............  Medrol Acetate           Pharmacia & Upjohn Co.
                          (methylprednisolone
                          acetate) Topical
                          Ointment, 0.25% and 1%.
NDA 013935.............  Herplex (idoxuridine)    Allergan, Inc., 2525
                          Ophthalmic Solution,     Dupont Dr., P.O. Box
                          0.1%.                    19534, Irvine, CA
                                                   92623-9534.
NDA 013993.............  Chromitope Sodium        Bracco Diagnostics
                          (sodium chromate Cr      Inc., 259 Prospect
                          51) Injection USP, 2     Plains Rd., Bldg. H,
                          millicuries (mCi)/vial   Monroe Township, NJ
                          and 200 microcuries      08831.
                          (uCi)/mL.
NDA 014006.............  Maxibolin                Organon USA, Inc.,
                          (ethylestrenol)          Subsidiary of Merck &
                          Elixir, 2 mg/5 mL.       Co., Inc., 2000
                                                   Galloping Hill Rd.,
                                                   Kenilworth, NJ 07033.
NDA 014214.............  NegGram (nalidixic       Sanofi-Aventis U.S.
                          acid) Tablets USP, 250   LLC, c/o Sanofi U.S.
                          mg, 500 mg, and 1 gram   Services Inc., 55
                          (g).                     Corporate Dr.,
                                                   Bridgewater, NJ
                                                   08807.
NDA 014295.............  Conray 400 (iothalamate  Mallinckrodt Inc., 675
                          sodium) Injection USP,   McDonnell Blvd.,
                          66.8%.                   Hazelwood, MO 63042.
NDA 016089.............  Rubratope-57             Bracco Diagnostics
                          (cyanocobalamin CO-57)   Inc.
                          Capsules, 0.5-1 uCi
                          and Rubratope-57 Kit
                          (cobalt chloride CO-
                          57, cyanocobalamin,
                          cyanocobalamin CO-57,
                          intrinsic factor).
NDA 016672.............  Ovral (ethinyl           Wyeth Pharmaceuticals
                          estradiol and            Inc.
                          norgestrel) Tablets,
                          0.05 mg/0.5 mg.
NDA 016692.............  M/6 Sodium Lactate       Baxter Healthcare
                          (sodium lactate)         Corp.
                          Injection USP, 1.87 g/
                          100 mL.
NDA 016696.............  Dextrose 10% and Sodium   Do.
                          Chloride 0.9%
                          Injection USP in
                          Plastic Container.
NDA 016708.............  Sodium Chromate Cr 51    Mallinckrodt Nuclear
                          Injection, 100           Medicine LLC., 2703
                          [micro]Ci/mL.            Wagner Place,
                                                   Maryland Heights, MO
                                                   63043.
NDA 016744.............  Noriday 1+50 FE          GD Searle LLC,
                          (mestranol and           Subsidiary of Pfizer
                          norethindrone) Tablets.  Inc., 235 East 42nd
                                                   St., New York, NY
                                                   10017.
NDA 016806.............  Ovral-28 (ethinyl        Wyeth Pharmaceuticals
                          estradiol and            Inc.
                          norgestrel) Tablets,
                          0.05 mg/0.5 mg.
NDA 016860.............  Eskalith (lithium        Noven Therapeutics,
                          carbonate) Capsules,     LLC., 11960 Southwest
                          300 mg.                  144th St., Miami, FL
                                                   33186.
NDA 017038.............  Sodium Chloride          B. Braun Medical Inc.,
                          Injection, 20 g/100 mL.  901 Marcon Blvd.,
                                                   Allentown, PA 18109.
NDA 017281.............  Technetium Tc99m         Lantheus Medical
                          Generator (Neutron).     Imaging, Inc., 331
                                                   Treble Cove Rd.,
                                                   North Billerica, MA
                                                   01862.
NDA 017283.............  Xenon Xe 133 Injection,  Lantheus Medical
                          6.3 mCi/mL.              Imaging, Inc.
NDA 017505.............  Noriday (mestranol and   GD Searle LLC.
                          norethindrone) Tablets.
NDA 017549.............  LidoPen (lidocaine HCl)  Meridian Medical
                          Injection, 10%.          Technologies, Inc.,
                                                   Subsidiary of Pfizer
                                                   Inc., 235 East 42nd
                                                   Street, New York, NY
                                                   10017.
NDA 017576.............  Ovcon-50 (ethinyl        Warner Chilcott Co.,
                          estradiol and            LLC, Union Street
                          norethindrone )          Road, 195 km 1.1,
                          Tablets USP, 0.05 mg/1   Fajrado, Puerto Rico
                          mg.                      00738.
NDA 017670.............  Sodium Chloride 0.45%    Hospira, Inc. 275
                          in Plastic Container,    North Field Dr., Lake
                          Irrigation.              Forest, IL 60045.
NDA 017756.............  Tylenol (acetaminophen)  Johnson & Johnson
                          Suppositories, 120 mg    Consumer Inc., McNeil
                          and 650 mg.              Consumer Healthcare
                                                   Division, 7050 Camp
                                                   Hill Rd., Fort
                                                   Washington, PA 19034.
NDA 017748.............  Noriday 1+50 (mestranol  GD Searle LLC.
                          and norethindrone)
                          Tablets.
NDA 018031.............  Inderide (propranolol    Wyeth Pharmaceuticals
                          HCl and                  Inc.
                          hydrochlorothiazide)
                          Tablets, 40 mg/25 mg
                          and 80 mg/25 mg.
NDA 018039.............  Loxitane IM (loxapine    Actavis Laboratories
                          HCl) Injection,          UT, Inc., Subsidiary
                          Equivalent to (EQ) 50    of Teva
                          mg base/mL.              Pharmaceuticals USA,
                                                   Inc., 425 Privet
                                                   Road, Horsham, PA
                                                   19044.
NDA 018104.............  Hylorel (guanadrel       Pharmacia and Upjohn
                          sulfate) Tablets, 10     Co.
                          mg and 25 mg.
NDA 018239.............  Propine (dipivefrin      Allergan, Inc.
                          HCl) Ophthalmic
                          Solution USP, 0.1%.
NDA 018254.............  Ringer's and Dextrose    Hospira Inc.
                          5% (calcium chloride,
                          dextrose, potassium
                          chloride, sodium
                          chloride) Injection
                          USP (in Plastic
                          Container).
NDA 018353.............  Flagyl I.V.              GD Searle LLC.
                          (metronidazole HCl)
                          for Injection, EQ 500
                          mg base/vial.
NDA 018388.............  Lidocaine HCl in         Hospira, Inc.
                          Dextrose 5% in Plastic
                          Container Injection.

[[Page 28324]]

 
NDA 018404.............  0.25% Acetic Acid         Do.
                          Irrigation Solution.
NDA 018406.............  PhysioSol (magnesium      Do.
                          chloride, potassium
                          chloride, sodium
                          acetate, sodium
                          chloride, sodium
                          gluconate) Irrigation
                          Solution.
NDA 018460.............  Dialyte (Peritoneal      B. Braun Medical Inc.
                          Dialysis Solution)
                          Pattern LM (calcium
                          chloride, dextrose,
                          magnesium chloride,
                          sodium acetate, sodium
                          chloride) with
                          Dextrose.
NDA 018465.............  Soyacal (soybean oil)    Grifols Biologicals
                          Injection, 10%.          Inc., 5555 Valley
                                                   Blvd., Los Angeles,
                                                   CA 90032.
NDA 018509.............  Baros (sodium            Mallinckrodt Inc.
                          bicarbonate, tartaric
                          acid) Effervescent
                          Granules, 460 mg/g;
                          420 mg/g).
NDA 018713.............  Mycelex (clotrimazole)   Bayer Healthcare
                          Troche/Lozenge, 10 mg.   Pharmaceuticals Inc.,
                                                   100 Bayer Blvd.,
                                                   Whippany, NJ 07981.
ANDA 018730............  Indomethacin Capsules    Zenith Laboratories,
                          USP, 25 mg and 50 mg.    Inc., 140 LeGrand
                                                   Ave., Northvale, NJ
                                                   07647.
NDA 018786.............  Soyacal(Soybean Oil)     Grifols Biologicals
                          Injection, 20%.          Inc., 5555 Valley
                                                   Blvd., Los Angeles,
                                                   CA 90032.
NDA 018807.............  Dialyte (Peritoneal      B. Braun Medical Inc.
                          Dialysis Concentrates)
                          (calcium chloride,
                          dextrose, magnesium
                          chloride, sodium
                          acetate, sodium
                          chloride) with
                          Dextrose.
NDA 018887.............  Intal (cromolyn sodium)  King Pharmaceuticals
                          Metered Dose Inhaler,    Inc., Subsidiary of
                          0.8 mg/inhalation.       Pfizer Inc., 235 East
                                                   42nd St., New York,
                                                   NY 10017.
NDA 018970.............  Liposyn III 20%          Hospira, Inc.
                          (soybean oil)
                          Injection.
NDA 018991.............  Liposyn II 20%            Do.
                          (safflower oil and
                          soybean oil) Injection.
NDA 018997.............  Liposyn II 10%            Do.
                          (safflower oil and
                          soybean oil) Injection.
NDA 019038.............  Calan (verapamil HCl)    G.D. Searle LLC.
                          Injection, 2.5 mg/mL.
NDA 019121.............  Bretylium Tosylate in    B. Braun Medical Inc.
                          5% Dextrose Injection.
NDA 019212.............  Theophylline and 5%       Do.
                          Dextrose Injection.
NDA 019229.............  Zinc Sulfate Injection,  Abraxis Pharmaceutical
                          EQ 1 mg Zinc/mL.         Products, 6133 North
                                                   River Rd., Suite 500,
                                                   Rosemont, IL 60018.
NDA 019350.............  Cupric Sulfate            Do.
                          Injection, EQ 0.4 mg
                          Copper/mL.
NDA 019415.............  Fertinex                 EMD Serono, Inc., One
                          (urofollitropin) for     Technology Pl.,
                          Subcutaneous             Rockland, MA 02370.
                          Injection, 75
                          international units
                          (IU)/ampule and 150 IU/
                          ampule, and Metrodin
                          (urofollitropin) for
                          Intramuscular
                          Injection, 75 IU)/
                          ampule and 150 IU/
                          ampule.
NDA 019510.............  Pepcid (famotidine)      Merck Sharp & Dohme
                          Injection, 10 mg/mL.     Corp., Subsidiary of
                                                   Merck & Co., Inc., 1
                                                   Merck Dr., P.O. Box
                                                   100, Whitehouse
                                                   Station, NJ 08889.
NDA 019514.............  Ionosol T and 5%         Hospira, Inc.
                          Dextrose Injection.
NDA 019515.............  Ionosol B and 5%          Do.
                          Dextrose Injection.
NDA 019641.............  Terazol 3 (terconazole)  Janssen
                          Vaginal Suppositories,   Pharmaceuticals,
                          80 mg.                   Inc., 1000 U.S.
                                                   Highway 202, Raritan,
                                                   NJ 08869.
NDA 019643.............  Mevacor (lovastatin)     Merck Sharp & Dohme
                          Tablets, 10 mg, 20 mg,   Corp.
                          and 40 mg.
NDA 019660.............  Tilade (nedocromil       King Pharmaceuticals
                          sodium) Metered Dose     Inc.
                          Inhaler, 1.75 mg/
                          inhalation.
NDA 019793.............  Pharmaseal Scrub Care    CareFusion 2200, Inc.,
                          (chlorhexidine           75 North Fairway Dr.,
                          gluconate) Sponge, 4%.   Vernon Hills, IL
                                                   60061.
NDA 019802.............  Heparin Sodium in        B. Braun Medical Inc.
                          Sodium Chloride
                          Injection.
NDA 019834.............  Plendil (felodipine)     AstraZeneca
                          Extended-Release         Pharmaceuticals LP,
                          Tablets, 2.5 mg, 5 mg,   1800 Concord Pike,
                          and 10 mg.               Wilmington, DE 19803.
NDA 019907.............  Optipranolol             Bausch & Lomb, Inc.,
                          (metipranolol HCl)       Subsidiary of Valeant
                          Ophthalmic Solution,     Pharmaceuticals
                          0.3%.                    International, Inc.,
                                                   400 Somerset
                                                   Corporate Blvd.,
                                                   Bridgewater, NJ
                                                   08807.
NDA 019933.............  Lactated Ringer's        Baxter Healthcare
                          (calcium chloride,       Corp.
                          potassium chloride,
                          sodium chloride,
                          sodium lactate)
                          Irrigation Solution.
NDA 020092.............  Dilacor XR (diltiazem    Allergan Sales, LLC,
                          HCl) Extended-Release    2525 Dupont Drive,
                          Capsules, 120 mg, 180    Irvine, CA 92612.
                          mg, and 240 mg.
NDA 020146.............  Nitrodisc                GD Searle LLC.
                          (nitroglycerin)
                          Transdermal System,
                          0.2 mg/hour (hr), 0.3
                          mg/hr, and 0.4 mg/hr.
NDA 020181.............  Liposyn III 30%          Hospira, Inc.
                          (soybean oil)
                          Injection.
NDA 020249.............  Pepcid Preservative      Merck Sharp & Dohme
                          Free (famotidine)        Corp.
                          Injection, 0.4 mg/mL.
NDA 020291.............  Combivent (albuterol     Boehringer Ingelheim
                          sulfate and              Pharmaceuticals Inc.,
                          ipratropium bromide)     900 Ridgebury Rd.,
                          Metered Dose Inhaler,    P.O. Box 368,
                          EQ 0.09 mg base/         Ridgefield, CT 06877.
                          inhalation; 0.018 mg/
                          inhalation.
NDA 020292.............  FerriSeltz (ferric       Otsuka Pharmaceutical
                          ammonium citrate)        Co., Ltd., 508
                          Powder for Oral          Carnegie Center Dr.,
                          Solution, 600 mg/        Princeton, NJ 08540.
                          packet.
ANDA 020360............  Hepatasol Sulfite-free   Baxter Healthcare
                          (amino acids)            Corp.
                          Injection, 8%.
NDA 020409.............  Nasarel (flunisolide)    Teva Branded
                          Nasal Spray, 0.029 mg/   Pharmaceutical
                          spray.                   Products R&D, Inc.,
                                                   74 NW 176th St.,
                                                   Miami, FL 33169.
NDA 020448.............  Imodium A-D (loperamide  Johnson & Johnson
                          HCl) Tablets             Consumer Inc.
                          (Chewable), 2 mg.
NDA 020506.............  Tiamate (diltiazem       Merck & Co., Inc.,
                          malate) Extended-        P.O. Box 1000, UG2C-
                          Release Tablets.         50, North Wales, PA
                                                   19454.

[[Page 28325]]

 
NDA 020518.............  Retrovir (zidovudine)    ViiV Healthcare Co.,
                          Tablets, 200 mg and      Five Moore Dr., P.O.
                          300 mg.                  Box 13398, Research
                                                   Triangle Park, NC
                                                   27709.
NDA 020569.............  Vitrasert (ganciclovir)  Bausch & Lomb Inc.
                          Implant, 4.5 mg.
NDA 020606.............  Imodium Multi-Symptom    Johnson & Johnson
                          Relief (loperamide HCl   Consumer Inc.
                          and simethicone)
                          Tablets (Chewable), 2
                          mg/125 mg.
NDA 020635.............  Levaquin (levofloxacin)  Janssen
                          Injection, EQ 250 mg/    Pharmaceuticals, Inc.
                          50 mL, EQ 500 mg/100
                          mL, and EQ 750 mg/150
                          mL.
NDA 020745.............  Zantac (ranitidine HCl)  Sanofi-Aventis U.S.
                          Tablets                  LLC, 55 Corporate
                          (Effervescent), EQ 75    Drive, Bridgewater,
                          mg base.                 NJ 08807.
NDA 020752.............  Pepcid RPD (famotidine)  Merck Sharp & Dohme
                          Orally Disintegrating    Corp.
                          Tablets, 20 mg and 40
                          mg.
NDA 020799.............  Floxin Otic (ofloxacin)  Daiichi Sankyo Co.,
                          Otic Solution, 0.3%.     Ltd., 399 Thornall
                                                   St., Edison, NJ
                                                   08837.
NDA 020813.............  Klonopin (clonazepam)    Hoffmann La-Roche,
                          Orally Disintegrating    Inc., c/o Genentech,
                          Tablets, 0.125 mg,       Inc., 1 DNA Way MS
                          0.25 mg, 0.5 mg, 1 mg,   #242, South San
                          and 2 mg.                Francisco, CA 94080.
NDA 020902.............  Pepcid AC (famotidine)   Johnson & Johnson
                          Tablets OTC, 10 mg.      Consumer Inc.
NDA 021097.............  Visicol (sodium          Salix Pharmaceuticals
                          phosphate, monobasic     Inc., Subsidiary of
                          monohydrate, and         Valeant
                          sodium phosphate         Pharmaceuticals North
                          dibasic anhydrous)       America LLC, 400
                          Tablets USP.             Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
NDA 021214.............  Rescula (unoprostone     R-Tech Ueno, Ltd., c/o
                          isopropyl) Ophthalmic    Sucampo Pharma
                          Solution, 0.15%.         Americas, LLC, 805
                                                   King Farm Blvd.,
                                                   Suite 550, Rockville,
                                                   MD 20850.
NDA 021224.............  Razadyne (galantamine    Janssen
                          hydrobromide) Oral       Pharmaceuticals, Inc.
                          Solution, 4 mg/mL.
NDA 021317.............  Bayer Extra Strength     Bayer Healthcare LLC,
                          Aspirin (aspirin)        100 Bayer Blvd.,
                          Tablets, 500 mg.         Whippany, NJ 07981.
NDA 021412.............  Tovalt ODT (zolpidem     Valeant
                          tartrate) Orally         Pharmaceuticals North
                          Disintegrating           America, LLC, 400
                          Tablets, 5 mg and 10     Somerset Corporate
                          mg.                      Blvd., Bridgewater,
                                                   NJ 08807.
NDA 021453.............  Zerit XR (stavudine)     Bristol-Myers Squibb
                          Extended-Release         Co., 5 Research
                          Capsules, 37.5 mg, 50    Parkway, Wallingford,
                          mg, 75 mg, and 100 mg.   CT 06492.
NDA 021483.............  Geodon (ziprasidone      Pfizer Inc., 235 East
                          HCl) Oral Suspension,    42nd St., New York,
                          EQ10 mg base/mL.         NY 10017.
NDA 021494.............  Axid (nizatidine) Oral   Braintree
                          Solution, 15 mg/mL.      Laboratories, Inc.,
                                                   60 Columbian St.
                                                   West, P.O. Box
                                                   850929, Braintree, MA
                                                   02185.
NDA 021589.............  Kemstro (baclofen)       UCB, Inc.,1950 Lake
                          Orally Disintegrating    Park Dr., Smyrna, GA
                          Tablets, 10 mg and 20    30080.
                          mg.
NDA 021595.............  Sanctura (trospium       Allergan, Inc.
                          chloride) Tablets, 20
                          mg.
NDA 021721.............  Levaquin (levofloxacin)  Janssen
                          Oral Solution, 25 mg/    Pharmaceuticals, Inc.
                          mL.
NDA 021763.............  Citalopram Hydrobromide  Valeant International
                          Orally Disintegrating    (Barbados) SRL
                          Tablets, EQ 10 mg        Welches, Christ
                          base, EQ 20 mg base,     Church, Barbados,
                          and EQ 40 mg base.       BB17154.
NDA 021864.............  Lybrel (ethinyl          Wyeth Pharmaceuticals
                          estradiol and            Inc.
                          levonorgestrel)
                          Tablets, 0.02 mg/0.09
                          mg.
NDA 022103.............  Sanctura XR (trospium    Allergan, Inc.
                          chloride) Extended-
                          Release Capsules, 60
                          mg.
NDA 022220.............  Trivaris (triamcinolone   Do.
                          acetonide) Injectable
                          Suspension, 80 mg/mL.
NDA 022294.............  Zidovudine Tablets, 60   Aurobindo Pharma
                          mg.                      Limited, c/o
                                                   Aurobindo Pharma USA,
                                                   Inc., 2400 Route 130
                                                   North, Dayton, NJ
                                                   08810.
NDA 022377.............  Alsuma (sumatriptan      Meridian Medical
                          succinate) Auto-         Technologies, Inc.,
                          Injector, EQ 6 mg base/  1945 Craig Rd., St.
                          0.5 mL Injectable.       Louis, MO 63146.
NDA 022411.............  Oleptro (trazodone HCl)  Angelini Pharma Inc.,
                          Extended-Release         8322 Helgerman Ct.,
                          Tablets, 150 mg and      Gaithersburg, MD
                          300 mg.                  20877.
NDA 022494.............  Sodium Fluoride F 18     National Institutes of
                          Injection, 10-200 mCi/   Health/National
                          mL.                      Cancer Institute,
                                                   Cancer Imaging
                                                   Program, 9609 Medical
                                                   Center Dr., Room 4-
                                                   W236, MSC 9729,
                                                   Bethesda, MD 20892-
                                                   9729.
NDA 022545.............  Tekamlo (aliskiren       Novartis
                          hemifumarate and         Pharmaceuticals
                          amlodipine besylate)     Corp., One Health
                          Tablets.                 Plaza, East Hanover,
                                                   NJ 07936.
ANDA 040032............  Cyclophosphamide         Roxane Laboratories,
                          Tablets USP, 25 mg and   Inc., 1809 Wilson
                          50 mg.                   Rd., Columbus, OH
                                                   43228.
ANDA 040262............  Leucovorin Calcium for   Pharmachemie B.V., c/o
                          Injection, EQ 350 mg     SICOR
                          base/vial.               Pharmaceuticals,
                                                   Inc., 19 Hughes,
                                                   Irvine, CA 92618.
ANDA 040772............  Fluorouracil Injection   Sandoz Inc., 100
                          USP, 50 mg/mL.           College Road West,
                                                   Princeton, NJ 08540.
ANDA 040793............  A-Methapred              Hospira, Inc.
                          (methylprednisolone
                          sodium succinate) for
                          Injection USP, EQ 40
                          mg base/vial.
ANDA 040827............  A-Methapred               Do.
                          (methylprednisolone
                          sodium succinate) for
                          Injection USP, EQ 125
                          mg base/vial.
NDA 050182.............  Erythrocin                Do.
                          (erythromycin
                          lactobionate) for
                          Injection USP.
NDA 050435.............  Geocillin                Pfizer, Inc.
                          (carbenicillin indanyl
                          sodium) Tablets, EQ
                          382 mg base.
NDA 050528.............  Duricef (cefadroxil)     Warner Chilcott Co.,
                          Tablets USP, EQ 1 g      Inc., 100 Enterprise
                          base.                    Drive, Rockaway, NJ
                                                   07866.
NDA 050545.............  Pipracil (piperacillin   Wyeth Pharmaceuticals
                          sodium) Injection.       Inc.
NDA 050590.............  Timentin (ticarcillin    GlaxoSmithKline.
                          disodium and
                          clavulanate potassium)
                          for Injection.

[[Page 28326]]

 
NDA 050658.............  Timentin Galaxy Plastic   Do.
                          Container(ticarcillin
                          disodium and
                          clavulanate potassium)
                          for Injection.
NDA 050664.............  Cefzil (cefprozil)       Corden Pharma Latina,
                          Tablets, 250 mg and      S.p.A. , c/o
                          500 mg.                  Clinipace, Inc., 4840
                                                   Pearl East Circle,
                                                   Suite 210E, Boulder,
                                                   CO 80301.
NDA 050665.............  Cefzil (cefprozil) Oral   Do.
                          Suspension, 125 mg/5
                          mL and 250 mg/5 mL.
ANDA 060076............  Streptomycin Sulfate     Pfizer Inc.
                          Powder for Injection,
                          EQ 1 g base/vial and
                          EQ 5 g base/vial.
ANDA 060111............  Streptomycin Sulfate      Do.
                          Powder for Injection,
                          EQ 1 g base/2.5 mL.
ANDA 060607............  Neomycin Sulfate         Lannett Co., Inc.,
                          Tablets, 500 mg.         9000 State Rd.,
                                                   Philadelphia, PA
                                                   19136.
ANDA 061578............  Poly-Rx (polymyxin B     X-GEN Pharmaceuticals,
                          sulfate USP) for         Inc., 300 Daniel
                          Prescription             Zenker Dr.,
                          Compounding.             Horseheads, NY 14845.
ANDA 061580............  Baci-Rx (bacitracinUSP)   Do.
                          for Prescription
                          Compounding.
ANDA 061645............  Econochlor               Alcon Laboratories,
                          (chloramphenicol)        Inc., 6201 South
                          Ophthalmic Solution      Freeway, TC-45, Fort
                          USP, 0.5%.               Worth, TX 76134-2099.
ANDA 061648............  Chloramphenicol           Do.
                          Ophthalmic Ointment,
                          1%.
ANDA 062118............  Cephalexin Capsules       Do.
                          USP, EQ 250 mg base
                          and EQ 500 mg base.
ANDA 062206............  Cefaclor for Oral         Do.
                          Suspension USP, EQ 125
                          mg base/5 mL, EQ 187
                          mg base/5 mL, EQ 250
                          mg base/5 mL, and EQ
                          375 mg base/5 mL.
ANDA 062339............  Statrol (neomycin        Alcon Laboratories,
                          sulfate and polymyxin    Inc.
                          B sulfate) Ophthalmic
                          Solution, EQ 3.5 mg
                          base/mL and 16,250
                          units/mL.
ANDA 062523............  Gentamicin Sulfate        Do.
                          Ophthalmic Solution
                          USP, EQ 0.3% base.
ANDA 062628............  Chloramphenicol           Do.
                          Ophthalmic Solution
                          USP, 0.5%.
ANDA 062691............  Timentin ADD-Vantage     GlaxoSmithKline.
                          (ticarcillin disodium
                          and clavulanate
                          potassium) for
                          Injection USP, EQ 3 g
                          base/vial and EQ 100
                          mg base/vial.
ANDA 062714............  Neomycin Sulfate and     Alcon Pharmaceuticals
                          Dexamethasone Sodium     Ltd., 6201 South
                          Phosphate Ophthalmic     Freeway, Fort Worth,
                          Solution, EQ 3.5 mg      TX 76134.
                          base/mL and EQ 0.1%
                          and.
ANDA 062721............  Neomycin and Polymyxin    Do.
                          B Sulfate and
                          Dexamethasone
                          Ophthalmic Suspension
                          USP, EQ 3.5 mg base/
                          mL; 10,000 units/mL;
                          0.1%.
ANDA 062822............  Pediotic (neomycin       Monarch
                          sulfate and polymyxin    Pharmaceuticals,
                          B sulfate and            Inc., Subsidiary of
                          hydrocortisone) Otic     Pfizer Inc., 235 East
                          Suspension USP.          42nd St., New York,
                                                   NY 10017-7555.
ANDA 063176............  Tobramycin Ophthalmic    Alcon Pharmaceuticals,
                          Solution USP, 0.3%.      Ltd.
ANDA 063208............  Cefazolin for Injection  Steri-Pharma, LLC, 429
                          USP, EQ 1 g base/100     South West St.,
                          mL vial.                 Syracuse, NY 13202.
ANDA 063216............  Cefazolin for Injection   Do.
                          USP, EQ 500 mg base/
                          100 mL vial.
ANDA 063283............  Amikacin Sulfate         Hospira, Inc.
                          Injection, EQ 62.5 mg
                          base/mL.
ANDA 064169............  Cefazolin for Injection  Fresenius Kabi USA,
                          USP, EQ 500 mg base/     LLC, Three Corporate
                          vial and EQ 1 g base/    Dr., Lake Zurich, IL
                          vial.                    60047.
ANDA 064170............  Cefazolin for Injection   Do.
                          USP, EQ 10 g base/vial
                          and EQ 20 g base/vial.
ANDA 065010............  Neo-Fradin (neomycin     X-GEN Pharmaceuticals,
                          sulfate) Oral Solution   Inc.
                          USP, EQ 87.5 mg base/5
                          mL.
ANDA 065011............  Cefoxitin (cefoxitin     Fresenius Kabi USA,
                          sodium) for Injection,   LLC.
                          EQ 10 g base/Vial.
ANDA 065012............  Cefoxitin for Injection   Do.
                          USP, EQ 1 g base/vial
                          and EQ 2 g base/vial.
ANDA 065245............  Ceftriaxone for           Do.
                          Injection USP, EQ 250
                          mg base/vial, EQ 500
                          mg base/vial, EQ 1 g
                          base/vial, and EQ 2 g
                          base/vial.
ANDA 065252............  Ceftriaxone for           Do.
                          Injection, EQ 10 g
                          base/vial.
ANDA 065324............  Amoxicillin Tablets for  Aurobindo Pharma
                          Oral Suspension USP,     Limited.
                          200 mg and 400 mg.
ANDA 065339............  Epirubicin HCl           Sandoz, Inc.
                          Injection, 50 mg/25 mL
                          and 200 mg/100 mL.
ANDA 065465............  Ceftriaxone for          Bedford Laboratories,
                          Injection USP, EQ 250    c/o PAREXEL
                          mg base/vial, EQ 500     International, 4600
                          mg base/vial, EQ 1 g     East-West Highway,
                          base/vial, and EQ 2 g    Suite 350, Bethesda,
                          base/vial.               MD 20814.
ANDA 065475............  Ceftriaxone for           Do.
                          Injection USP, EQ 10 g
                          base/vial.
ANDA 070088............  Ibuprofen Tablets USP,   BASF Corp., 5738
                          600 mg.                  County Rd. 4, Bishop,
                                                   TX 78343.
ANDA 070187............  Disopyramide Phosphate   Ivax Pharmaceuticals
                          Capsules USP, EQ 150     Inc., Subsidiary of
                          mg base.                 Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Road, Horsham, PA
                                                   19044.
ANDA 070587............  Bupivacaine HCl          Hospira, Inc.
                          Injection USP, 0.75%.
ANDA 070659............  Clonidine HCl Tablets,   Teva Pharmaceuticals
                          0.3 mg.                  USA Inc., 1090
                                                   Horsham Rd., P.O. Box
                                                   1090, North Wales, PA
                                                   19454.
ANDA 070702............  Clonidine HCl Tablets,    Do.
                          0.2 mg.
ANDA 070747............  Clonidine HCl Tablets,    Do.
                          0.1 mg.
ANDA 070804............  Metaproterenol Sulfate   Mylan Specialty, L.P.,
                          Inhalation Solution      781 Chestnut Ridge
                          USP, 0.6%.               Rd., P.O. Box 4310,
                                                   Morgantown, WV 26504.
ANDA 071067............  Methyldopa Tablets USP,  Teva Pharmaceuticals
                          500 mg.                  USA, Inc.

[[Page 28327]]

 
ANDA 071101............  Clonidine HCl Tablets    Duramed
                          USP, 0.3 mg.             Pharmaceuticals,
                                                   Inc., 2 Quaker Rd.,
                                                   P.O. Box 2900,
                                                   Pomona, NY 10970.
ANDA 071102............  Clonidine HCl Tablets     Do.
                          USP, 0.2 mg.
ANDA 071103............  Clonidine HCl Tablets     Do.
                          USP, 0.1 mg.
ANDA 071105............  Methyldopa Tablets USP,  Teva Pharmaceuticals
                          125 mg.                  USA, Inc.
ANDA 071106............  Methyldopa Tablets USP,   Do.
                          250 mg.
ANDA 071426............  Vincasar PFS             Teva Parenteral
                          (vincristine sulfate)    Medicines Inc., 19
                          Injection USP, 1 mg/mL.  Hughes, Irvine, CA
                                                   92618.
ANDA 071584............  Diazepam Injection USP,  Hospira, Inc.
                          5 mg/mL.
ANDA 071786............  Metaproterenol Sulfate   Mylan Specialty L.P.
                          Inhalation Solution
                          USP, 0.4%.
ANDA 072323............  Acetylcysteine Solution  Roxane Laboratories,
                          USP, 10%.                Inc.
ANDA 072324............  Acetylcysteine Solution   Do.
                          USP, 20%.
ANDA 073034............  Metaproterenol Sulfate   G&W Laboratories Inc.,
                          Oral Solution USP, 10    111 Coolidge St.,
                          mg/5 mL.                 South Plainfield, NJ
                                                   07080.
ANDA 073636............  Dipivefrin HCl           Alcon Pharmaceuticals,
                          Ophthalmic Solution      Ltd.
                          USP, 0.1%.
ANDA 073676............  Atenolol Tablets, 50 mg  GD Searle LLC.
                          and 100 mg.
ANDA 074023............  Ranitidine Tablets USP,  Mylan Pharmaceuticals
                          150 mg and 300 mg.       Inc.
ANDA 074160............  Bumetanide Injection     Hospira, Inc.
                          USP, 0.25 mg/mL.
ANDA 074269............  Cimetidine in Sodium      Do.
                          Chloride 0.9%
                          Injection USP, EQ6 mg
                          base/mL).
ANDA 074300............  Lorazepam Injection       Do.
                          USP, 2 mg/mL and 4 mg/
                          mL.
ANDA 074396............  Enflurane Inhalation ,   Piramal Critical Care,
                          99.9%.                   Inc., 3950 Schelden
                                                   Circle, Bethlehem, PA
                                                   18017.
ANDA 074546............  Clozapine Tablets USP,   Sandoz, Inc.
                          25 mg and 100 mg.
ANDA 074632............  Atracurium Besylate      Hospira, Inc.
                          Injection, 10 mg/mL.
ANDA 074851............  Levobunolol HCl          Alcon Laboratories,
                          Ophthalmic Solution      Inc.
                          USP, 0.25%.
ANDA 074927............  Etodolac Tablets USP,    Lehigh Valley
                          400 mg.                  Technologies, Inc.,
                                                   514 North 12th St.,
                                                   Allentown, PA 18102.
ANDA 075117............  Orapred (prednisolone    Concordia
                          sodium phosphate) Oral   Pharmaceuticals,
                          Solution, EQ 15 mg       Inc., c/o Mapi USA,
                          base/5 mL.               Inc., 2343 Alexandria
                                                   Dr., Suite 100,
                                                   Lexington, KY 40504.
ANDA 075436............  Paclitaxel Injection     Accord Healthcare
                          USP, 6 mg/mL.            Inc., 1009 Slater
                                                   Rd., Suite 210-B,
                                                   Durham, NC 27703.
ANDA 075721............  Leuprolide Acetate       Genzyme Corp., 500
                          Injection, 1 mg/0.2 mL.  Kendall St.,
                                                   Cambridge, MA 02142.
ANDA 075963............  Tramadol HCl Tablets,    Ivax Pharmaceuticals
                          50 mg.                   Inc.
ANDA 076234............  Flavoxate HCl Tablets,   Impax Laboratories,
                          100 mg.                  Inc., 30831 Huntwood
                                                   Ave., Hayward, CA
                                                   94544.
ANDA 076296............  Vincristine Sulfate      Fresenius Kabi USA,
                          Injection USP, 1 mg/mL.  LLC.
ANDA 076394............  Amiodarone HCl           Par Sterile Products,
                          Injection, 50 mg/mL.     LLC, Morris Corporate
                                                   Center 2, One Upper
                                                   Pond Rd., Parsippany,
                                                   NJ 07054.
ANDA 076401............  Vincristine Sulfate      Fresenius Kabi USA,
                          Injection USP, 1 mg/mL.  LLC.
ANDA 076414............  Milrinone Lactate in 5%  B. Braun Medical Inc.
                          Dextrose Injection, EQ
                          20 mg base/100 mL.
ANDA 076563............  Diltiazem HCl Extended-  Nesher Pharmaceuticals
                          Release Capsules USP,    (USA) LLC, 13910 St.
                          120 mg, 180 mg, 240      Charles Rock Rd.,
                          mg, 300 mg, 360 mg,      Bridgeton, MO 63044.
                          420 mg.
ANDA 076699............  Parcopa (carbidopa and   UCB, Inc., 1950 Lake
                          levodopa) Orally         Park Dr., Bldg. 2100,
                          Disintegrating           Smyrna, GA 30080.
                          Tablets, 10 mg/100 mg,
                          25 mg/100 mg, and 25
                          mg/250 mg.
ANDA 077275............  Didanosine Tablets for   Aurobindo Pharma
                          Oral Suspension USP,     Limited.
                          100 mg, 150 mg, and
                          200 mg.
ANDA 077774............  Stavudine for Oral        Do.
                          Solution USP, 1 mg/mL.
ANDA 077887............  Carvedilol Tablets USP,  Hikma Pharmaceuticals,
                          3.125 mg, 6.25 mg,       c/o West-Ward
                          12.5 mg, 25 mg.          Pharmaceuticals
                                                   Corp., 401 Industrial
                                                   Way West, Eatontown,
                                                   NJ 07724.
ANDA 077968............  Alprazolam Extended-     Impax Laboratories,
                          Release Tablets, 0.5     Inc.
                          mg, 1 mg, 2 mg, and 3
                          mg.
ANDA 077996............  Alprazolam Extended-      Do.
                          Release Tablets, 0.5
                          mg, 1 mg, 2 mg, 3 mg.
ANDA 078112............  Didanosine for Oral      Aurobindo Pharma
                          Solution USP, 10 mg/mL.  Limited.
ANDA 078240............  Carvedilol Tablets,      Pliva Hrvatska d.o.o.,
                          3.125 mg, 6.25 mg,       Subsidiary of Teva
                          12.5 mg, and 25 mg.      Pharmaceutical
                                                   Industries Ltd., 425
                                                   Privet Rd., Horsham,
                                                   PA 19044.
ANDA 078254............  Atenolol Tablets USP,    Northstar Healthcare
                          25 mg, 50 mg, and 100    Holdings, c/o Quality
                          mg.                      Regulatory
                                                   Consultants, 1966
                                                   Anglers Cove, Vero
                                                   Beach, FL 32963.
ANDA 078285............  Bicalutamide Tablets     Roxane Laboratories,
                          USP, 50 mg.              Inc.
ANDA 078298............  Sumatriptan Succinate    Hikma Pharmaceuticals.
                          Tablets USP, EQ 25 mg
                          base, EQ 50 mg base,
                          EQ 100 mg base.
ANDA 078310............  Lamotrigine Tablets      Pharmascience Inc., c/
                          USP, 25 mg, 100 mg,      o Pharmascience
                          150 mg, and 200 mg.      Laboratories Inc.,
                                                   295 Firetower Rd.,
                                                   Tonawanda, NY 14150.
ANDA 078334............  Granisol (granisetron    PediatRx, Inc., c/o
                          HCl Oral Solution, 2     Cardinal Health
                          mg base/10mL.            Regulatory Sciences,
                                                   7400 West 110th St.,
                                                   Commerce Plaza II,
                                                   Suite 300, Overland
                                                   Park, KS 66210.
ANDA 078374............  Metoclopramide Tablets   Northstar Healthcare
                          USP, EQ 5 mg base and    Holdings.
                          EQ 10 mg base.
ANDA 078408............  Vinorelbine Injection    Sandoz Inc.
                          USP, EQ 10 mg base/mL.

[[Page 28328]]

 
ANDA 078501............  Dronabinol Capsules      Insys Therapeutics,
                          USP, 2.5 mg, 5 mg, and   Inc., 1333 South
                          10 mg.                   Spectrum Blvd., Suite
                                                   100, Chandler, AZ
                                                   85286.
ANDA 078577............  Levofloxacin Injection,  Hospira Inc.
                          EQ 750 mg/30 mL and EQ
                          500 mg/20 mL.
ANDA 078782............  Gabapentin Tablets USP,  Hikma Pharmaceuticals.
                          600 mg and 800 mg.
ANDA 078808............  Granisetron HCl          Sandoz Inc.
                          Injection USP, EQ 0.1
                          mg base/mL.
ANDA 078812............  Oxaliplatin Injection     Do.
                          USP, 50 mg/10 mL and
                          100 mg/20 mL.
ANDA 078952............  Glimepiride Tablets      Hikma Pharmaceuticals.
                          USP, 1 mg, 2 mg, and 4
                          mg.
ANDA 079033............  Fomepizole Injection,    Mylan Institutional
                          1.5 g/1.5 mL.            LLC, 4901 Hiawatha
                                                   Dr., Rockford, IL
                                                   61103.
ANDA 080020............  Isopto Cetamide          Alcon Laboratories,
                          (sulfacetamide sodium)   Inc.
                          Ophthalmic Solution,
                          15%.
ANDA 080021............  Sulfacetamide Sodium      Do.
                          Ophthalmic Ointment,
                          10%.
ANDA 080229............  Naphcon Forte             Do.
                          (naphazoline HCl)
                          Ophthalmic Solution
                          USP 0.1%.
ANDA 080248............  Albalon (naphazoline     Allergan, Inc.
                          HCl) Ophthalmic
                          Solution USP, 0.1%.
ANDA 080472............  Hytone (hydrocortisone)  Valeant International
                          Cream, 1% and 2.5%.      (Barbados) SRL, c/o
                                                   Valeant
                                                   Pharmaceuticals North
                                                   America LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
ANDA 080473............  Hytone (hydrocortisone)   Do.
                          Lotion, 1% and 2.5%.
ANDA 081043............  Prednisolone Sodium      Alcon Pharmaceuticals,
                          Phosphate Ophthalmic     Ltd.
                          Solution USP, EQ 0.11%
                          phosphate.
ANDA 081044............  Prednisolone Sodium       Do.
                          Phosphate Ophthalmic
                          Solution USP, EQ 0.9%
                          phosphate.
ANDA 083205............  Orabase HCA              Colgate-Palmolive Co.,
                          (hydrocortisone          909 River Rd., P.O.
                          acetate) Topical         Box 1343, Piscataway,
                          Paste, 0.5%.             NJ 08855-1343.
ANDA 083342............  Maxidex (dexamethasone   Alcon Laboratories,
                          sodium phosphate)        Inc.
                          Ophthalmic Ointment,
                          EQ 0.05% phosphate.
ANDA 084645............  Chlordiazepoxide HCl     Upsher-Smith
                          Capsules USP, 25 mg.     Laboratories, Inc.
ANDA 084927............  Methocarbamol Tablets    Impax Laboratories,
                          USP, 500 mg.             Inc.
ANDA 084928............  Methocarbamol Tablets     Do.
                          USP, 750 mg.
ANDA 085000............  Chlordiazepoxide HCl     Hikma Pharmaceuticals.
                          Capsules USP, 10 mg.
ANDA 085014............  Chlordiazepoxide HCl      Do.
                          Capsules USP, 5 mg.
ANDA 085095............  Statobex-G               Teva Pharmaceuticals
                          (phendimetrazine         USA, Inc.
                          tartrate) Tablets, 35
                          mg.
ANDA 085294............  Chlordiazepoxide HCl     Hikma Pharmaceuticals.
                          Capsules USP, 25 mg.
ANDA 085380............  Butisol Sodium           Meda Pharmaceuticals
                          (butabarbital sodium)    Inc., 265 Davidson
                          Oral Solution USP, 30    Ave., Suite #4300,
                          mg/5 mL.                 Somerset, NJ 08873.
ANDA 085734............  Ammonium Chloride        B. Braun Medical Inc.
                          Injection USP, 40 mEQ/
                          100 mL.
ANDA 085981............  Hydrocortisone Acetate   X-Gen Pharmaceuticals,
                          USP Micronized for       Inc.
                          Prescription
                          Compounding, 100%.
ANDA 085982............  Hydro-Rx                  Do.
                          (hydrocortisone) USP
                          Micronized for
                          Prescription
                          Compounding, 100%.
ANDA 085995............  Pediatric LTA Kit        Hospira, Inc.
                          (lidocaine HCl)
                          Topical Solution USP,
                          2%.
ANDA 086535............  Acticort                 Baker Norton
                          (hydrocortisone)         Pharmaceuticals Inc.,
                          Lotion USP, 1%.          8800 N.W. 36 St.,
                                                   Miami, FL 33178-2404.
ANDA 086911............  Phentermine HCl          Teva Pharmaceuticals
                          Capsules USP, 30 mg.     USA, Inc.
ANDA 087547............  Isopto Cetapred          Alcon Laboratories,
                          (sulfacetamide sodium    Inc.
                          and prednisolone
                          acetate) Ophthalmic
                          Ointment USP, 10%/
                          0.25%.
ANDA 087771............  Cetapred (sulfacetamide   Do.
                          sodium and
                          prednisolone acetate)
                          Ophthalmic Ointment
                          USP, 10%/0.25%.
ANDA 087907............  Epinephrine Inhalation   Armstrong
                          Aerosol USP, 0.2 mg/     Pharmaceuticals,
                          inhalation).             Inc., 25 John Rd.,
                                                   Canton MA 02021.
ANDA 088613............  Phentermine HCl          Teva Pharmaceuticals
                          Capsules USP, 30 mg.     USA, Inc.
ANDA 088614............  Phentermine HCl           Do.
                          Capsules USP, 30 mg.
ANDA 088630............  Pseudoephedrine HCl and   Do.
                          Triprolidine HCl
                          Tablets, 60 mg/2.5 mg.
ANDA 088631............  Butabarbital Sodium       Do.
                          Tablets, 30 mg.
ANDA 088632............  Butabarbital Sodium       Do.
                          Tablets, 15 mg.
ANDA 088797............  Phentermine HCl          USL Pharma Inc., 301
                          Capsules USP, 30 mg.     South Cherokee St.,
                                                   Denver, CO 80223
ANDA 088910............  Phentermine HCl Tablets   Do.
                          USP, 37.5 mg.
ANDA 088917............  Phentermine HCl Tablets   Do.
                          USP, 37.5.
ANDA 088999............  Dipyridamole Tablets     Glenmark Generics
                          USP, 25 mg.              Limited, c/o Glenmark
                                                   Generics Inc., USA,
                                                   750 Corporate Dr.,
                                                   Mahwah, NJ 07430.
ANDA 089000............  Dipyridamole Tablets      Do.
                          USP, 50 mg.
ANDA 089001............  Dipyridamole Tablets      Do.
                          USP, 75 mg.
ANDA 089068............  Sulfacetamide Sodium     Alcon Pharmaceuticals,
                          Ophthalmic Solution,     Ltd.
                          30%.
ANDA 089172............  Tropicamide Ophthalmic    Do.
                          Solution, 1%.
ANDA 089422............  Imipramine HCl Tablets   Par Pharmaceutical
                          USP, 10 mg.              Inc., One Ram Ridge
                                                   Rd., Spring Valley,
                                                   NY 10977.
ANDA 089440............  Hydrocortisone Acetate   Vintage
                          and Pramoxine HCl        Pharmaceuticals, 150
                          Topical Aerosol, 1%/1%.  Vintage Dr.,
                                                   Huntsville, AL 35811.

[[Page 28329]]

 
ANDA 089497............  Imipramine HCl Tablets   Par Pharmaceutical
                          USP, 25 mg.              Inc.
ANDA 089628............  Leucovorin Calcium for   Pharmachemie USA Inc.,
                          Injection, EQ 50 mg      323 Davis St.,
                          base/vial.               Northborough, MA
                                                   01532.
ANDA 089681............  Bromfed-DM               Wockhardt Bio AG, c/o
                          (brompheniramine         Morton Grove
                          maleate,                 Pharmaceuticals,
                          dextromethorphan         Inc., 6451 Main St.,
                          hydrobromide, and        Morton Grove, IL
                          pseudoephedrine HCl)     60053.
                          Syrup, 2 mg/5 mL; 10mg/
                          5 mL; 30mg/5 mL.
ANDA 089915............  Leucovorin Calcium for   Pharmachemie USA Inc.
                          Injection, EQ 100 mg
                          base/vial.
ANDA 090098............  Tretinoin Cream USP,     Allergan Sales, LLC.
                          0.0375%.
ANDA 090137............  Irinotecan HCl           Sandoz Inc.
                          Injection, 40 mg/2 mL
                          and 100 mg/5 mL.
ANDA 090190............  Pramipexole               Do.
                          Dihydrochloride
                          Tablets, 0.125 mg,
                          0.25 mg, 0.5 mg, 0.75
                          mg, 1 mg, and 1.5 mg.
ANDA 090220............  Adenosine Injection      Wockhardt Limited, c/o
                          USP, 3 mg/mL.            Wockhardt USA LLC, 20
                                                   Waterview Blvd., 3rd
                                                   Floor, Parsippany, NJ
                                                   07054.
ANDA 090300............  Children's Cetirizine    Cypress
                          HCl Allergy and Hives    Pharmaceutical, Inc.,
                          Relief Oral Solution     10 North Park Place,
                          OTC, 5 mg/5 mL.          Suite 210,
                                                   Morristown, NJ 07960.
ANDA 090751............  Cetirizine HCl Oral      Aurobindo Pharma
                          Solution USP, 5 mg/5     Limited.
                          mL.
ANDA 090985............  Octreotide Acetate       Wockhardt Limited.
                          Preservative Free
                          Injection EQ 0.05 mg
                          base/mL, EQ 0.1 mg
                          base/mL, and EQ 0.5 mg
                          base/mL.
ANDA 090986............  Octreotide Acetate        Do.
                          Injection EQ 0.2 mg
                          base/mL and EQ 1 mg
                          base/mL.
ANDA 091068............  Ceftriaxone for          Agila Specialties
                          Injection USP, EQ 10 g   Private Limited, c/o
                          base/vial.               Agila Specialties
                                                   Inc., 201 South Main
                                                   St., Suite 3,
                                                   Lambertville, NJ
                                                   08530.
ANDA 091185............  Topiramate Tablets USP,  Hikma Pharmaceuticals.
                          25 mg, 50 mg, 100 mg,
                          and 200 mg.
ANDA 091293............  Idarubicin HCl           Sandoz Inc.
                          Injection, 1 mg/mL.
ANDA 091299............  Fluorouracil Injection    Do.
                          USP, 2.5 g/50 mL and 5
                          g/100 mL.
NDA 200045.............  Amturnide (aliskiren     Novartis
                          hemifumarate,            Pharmaceuticals Corp.
                          amlodipine,
                          andhydrochlorothiazide
                          ) Tablets.
ANDA 200146............  Doxorubicin HCl          Sandoz Inc.
                          Injection USP, 2 mg/mL.
NDA 200199.............  Topotecan Injection, EQ   Do.
                          1 mg base/mL, EQ 3 mg
                          base/3 mL, and EQ 4 mg
                          base/4 mL.
ANDA 201211............  Bromfenac Sodium         Coastal
                          Ophthalmic Solution,     Pharmaceuticals, 1240
                          EQ 0.09% acid.           Sugg Parkway,
                                                   Greenville, NC 27834.
NDA 201917.............  Incivek (telaprevir)     Vertex
                          Tablets, 375 mg.         Pharmaceuticals,
                                                   Inc., 50 Northern
                                                   Ave., Boston, MA
                                                   02210.
NDA 202088.............  Suprenza (phentermine    Citius
                          HCl) Orally              Pharmaceuticals, LLC,
                          Disintegrating           11 Commerce Dr.,
                          Tablets, 15 mg, 30 mg,   First Floor,
                          and 37.5 mg.             Cranford, NJ 07016.
ANDA 202209............  Tretinoin Cream USP,     Allergan Sales, LLC.
                          0.075%.
NDA 202513.............  Gelnique (oxybutynin)     Do.
                          Gel, 3%.
NDA 203595.............  Suclear (magnesium       Braintree
                          sufate, polyethylene     Laboratories, Inc.
                          glycol 3350, potassium
                          chloride, potassium
                          sulfate, sodium
                          bicarbonate, sodium
                          chloride, and sodium
                          sulfate) Oral Solution.
NDA 204508.............  Clinolipid 20% (olive    Baxter Healthcare
                          oil and soybean oil)     Corp.
                          USP, 16%/4%.
NDA 206510.............  Dutrebis (lamivudine     Merck Sharp & Dohme
                          and raltegravir          Corp.
                          potassium) Tablets,
                          150 mg/EQ 300 mg base.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Director, Center for 
Drug Evaluation and Research, by the Commissioner, approval of the 
applications listed in table 1, and all amendments and supplements 
thereto, is hereby withdrawn. Introduction or delivery for introduction 
into interstate commerce of products without approved new drug 
applications violates section 301(a) and (d) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are 
listed in table 1 that are in inventory on the date that this notice 
becomes effective (see the DATES section) may continue to be dispensed 
until the inventories have been depleted or the drug products have 
reached their expiration dates or otherwise become violative, whichever 
occurs first.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12908 Filed 6-20-17; 8:45 am]
 BILLING CODE 4164-01-P