Document ID: FDA-2016-N-0002-0031
Agency: fda
Document Type: Notice
Title: Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications
and 158 Abbreviated New Drug Applications
Posted Date: 2016-10-04T04:00Z

[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68427-68432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23893]

[[Page 68427]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0002]

Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug 
Applications and 158 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 44 new drug applications (NDAs) and 158 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be withdrawn.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: Effective Date: November 3, 2016.

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.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 005264.............  Heparin Sodium           Hospira, Inc., 275
                          Injection.               North Field Dr.,
                                                   Bldg. H2-2, Lake
                                                   Forest, IL 60045-
                                                   5046.
NDA 009470.............  Xylocaine Viscous        Fresenius Kabi USA
                          (lidocaine               LLC, Three Corporate
                          hydrochloride (HCl))     Dr., Lake Zurich, IL
                          Solution.                60047.
NDA 009698.............  Miltown (meprobamate)    Meda Pharmaceuticals,
                          Tablets, 200             Inc., 265 Davidson
                          milligrams (mg) and      Ave., Suite 300,
                          400 mg.                  Somerset, NJ 08873-
                                                   4120.
NDA 009939.............  Senokot Granules         Purdue Products, L.P.,
                          (sennosides), 15 mg.     One Stamford Forum,
                                                   Stamford, CT 06901.
NDA 010382.............  Tempra (acetaminophen)   Bristol-Myers Squibb
                          Syrup, 160 mg/5          Co., P.O. Box 4000,
                          milliliters (mL).        Princeton, NJ 88543-
                                                   4000.
NDA 011228.............  Liquamar                 Organon USA Inc.,
                          (phenprocoumon)          Subsidiary of Merck &
                          Tablets.                 Co., Inc., 2000
                                                   Galloping Hill Rd.,
                                                   Kenilworth, NJ 07033.
NDA 011613.............  Ionamin (phentermine     UCB, Inc., 1950 Lake
                          resin complex)           Park Dr., Smyrna, GA
                          Capsules, 15 mg and 30   30080.
                          mg.
NDA 011738.............  Numorphan (oxymorphone   Endo Pharmaceuticals,
                          HCl) Suppositories, 5    Inc., 100 Endo Blvd.,
                          mg.                      Chadds Ford, PA
                                                   19317.
NDA 012365.............  Soma Compound            Meda Pharmaceuticals,
                          (carisoprodol and        Inc.
                          aspirin) Tablets.
NDA 012940.............  Isordil (isosorbide      Valeant International
                          dinitrate) Sublingual    Bermuda, c/o Valeant
                          Tablets, 2.5 mg, 5 mg,   Pharmaceuticals North
                          and 10 mg.               America, LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
NDA 013483.............  Drixoral/Disophrol       Merck Consumer Care,
                          (dexbrompheniramine      556 Morris, Ave.,
                          maleate and              Summit, NJ 07901.
                          pseudoephedrine
                          sulfate) Extended-
                          Release Tablets, 6 mg/
                          120 mg.
NDA 014005.............  Maxibolin                Organon USA Inc.
                          (ethylestrenol)
                          Tablets.
NDA 017087.............  Ethrane (enflurane USP)  Baxter Healthcare
                                                   Corp., 32650 N.
                                                   Wilson Rd., Round
                                                   Lake, IL 60073.
NDA 017689.............  Methadone HCl Syrup....  Sandoz, Inc., 4700
                                                   Sandoz, Dr., Wilson,
                                                   NC 27893.
NDA 018766.............  Ansaid (flurbiprofen)    Pharmacia & Upjohn
                          Tablets, 50 mg and 100   Co., c/o Pfizer,
                          mg.                      Inc., 235 East 42nd
                                                   St., New York, NY
                                                   10017.
NDA 018812.............  Sulfamethoxazole and     Teva Pharmaceuticals
                          Trimethoprim Oral        USA, Inc., 1090
                          Suspension USP, 200 mg/  Horsham Rd., P.O. Box
                          5 mL and 40 mg/5 mL.     1090, North Wales, PA
                                                   19454.
NDA 019304.............  Tricor (fenofibrate)     AbbVie Inc., 1 N.
                          Micronized Capsules,     Waukegan Rd., Dept.
                          67 mg, 134 mg, and 200   PA77/Bldg. AP30,
                          mg.                      North Chicago, IL
                                                   60064.
NDA 019384.............  Noroxin (norfloxacin)    Merck Sharp & Dohme
                          Tablets, 400 mg.         Corp., 351 North
                                                   Sumneytown Pike, P.O.
                                                   Box 1000, North
                                                   Wales, PA 19454.
NDA 020005.............  Cardene SR (nicardipine  Chiesi USA, Inc., 1255
                          HCl) Extended-Release    Crescent Green Dr.,
                          Capsules, 30 mg, 45      Suite 250, Cary, NC
                          mg, and 60 mg.           27518.
NDA 020073.............  Romazicon (flumazenil)   Hoffman-LaRoche, Inc.,
                          Injection.               c/o Genetech, Inc., 1
                                                   DNA Way MS #241B,
                                                   South San Francisco,
                                                   CA 94080-4900.
NDA 020084.............  Iobenguane Sulfate I-    Pharmalucence, 10
                          131 Injection, 2.3       DeAngelo Dr.,
                          millicuries.             Bedford, MA 01730.
NDA 020107.............  Novamine (amino acids)   Baxter Healthcare
                          Injection.               Corp.
NDA 020229.............  Leustatin (cladribine)   Janssen
                          Injection, 1 mg/mL.      Pharmaceuticals Inc.,
                                                   920 Route 202 South,
                                                   P.O. Box 300,
                                                   Raritan, NJ 08869-
                                                   0602.
NDA 020251.............  Zantac (ranitidine HCl)  Glaxo Group Limited,
                          Effervescent Tablets,    England d/b/a
                          25 mg and 150 mg         GlaxoSmithKline, Five
                          Zantac (ranitidine       Moore Dr., P.O. Box
                          HCl) Effervescent        13398, Research
                          Granules, 150 mg.        Triangle Park, NC
                                                   27709.
NDA 020312.............  Univasc (moexipril HCl)  UCB, Inc.
                          Tablets, 7.5 mg and 15
                          mg.
NDA 020346.............  Zyrtec (cetirizine HCl)  Johnson and Johnson
                          Syrup, 1 mg/mL.          Consumer Inc., McNeil
                                                   Consumer Healthcare
                                                   Division, 7050 Camp
                                                   Hill Rd., Fort
                                                   Washington, PA 19034-
                                                   2299.
NDA 020410.............  Gastromark (ferumoxsil)  AMAG Pharmaceuticals,
                          Oral Suspension.         100 Haydon Ave.,
                                                   Lexington, MA 02421.

[[Page 68428]]

 
NDA 020416.............  Feridex I.V.             Do.
                          (ferumoxides)
                          Injection.
NDA 020460.............  Cytovene (ganciclovir)   Roche Palo Alto LLC, c/
                          Capsules, 250 mg and     o Genentech, Inc., 1
                          500 mg.                  DNA Way, MS#241B,
                                                   South San Francisco,
                                                   CA 94080-4990.
NDA 020575.............  DentiPatch (lidocaine).  Noven Pharmaceuticals,
                                                   Inc., 11960 SW. 144th
                                                   St., Miami, FL 33186.
NDA 020638.............  Vistide (cidofovir)      Gilead Sciences, Inc.,
                          Injection, Equivalent    333 Lakeside Dr.,
                          to (EQ) 75 mg base/mL.   Foster City, CA
                                                   94404.
NDA 020729.............  Uniretic (moexipril HCl  UCB, Inc.
                          and
                          hydrochlorothiazide)
                          Tablets, 7.5 mg/12.5
                          mg, 15 mg/12.5 mg, and
                          15 mg/25 mg.
NDA 021044.............  Palladone                Rhodes Pharmaceuticals
                          (hydromorphone HCl)      L.P., 498 Washington
                          Extended-Release         St., Coventry, RI
                          Capsules.                02816.
NDA 021046.............  Celexa (citalopram       Forest Laboratories,
                          hydrobromide) EQ 10 mg   Inc., Harborside
                          base/5 mL Oral           Financial Center,
                          Solution.                Plaza V, Suite 1900,
                                                   Jersey, City, NJ
                                                   07311.
NDA 021378.............  Combunox (Oxycodone HCl  Do.
                          and Ibuprofen) Tablets.
NDA 021671.............  DepoDur (morphine        Pacira
                          sulfate) Extended-       Pharmaceuticals,
                          Release Injection.       Inc., 10450 Science
                                                   Center Dr., San
                                                   Diego, CA 92121.
NDA 021693.............  Rybix ODT (tramadol      Shionogi, Inc., 300
                          HCl) Orally              Campus Dr., Suite
                          Disintegrating Tablets.  300, Florham Park, NJ
                                                   07932.
NDA 021768.............  Fludeoxyglucose F18      Weill Medical College
                          (FDG) Injection.         of Cornell
                                                   University, c/o
                                                   Citigroup Biomedical
                                                   Imaging Center, 516
                                                   East 72nd St., New
                                                   York, NY 10021.
NDA 022244.............  Lusedra (fospropofol     Eisai, Inc., 155 Tice
                          disodium) Injection.     Blvd., Woodcliff
                                                   Lake, NJ 07677.
NDA 022312.............  Docetaxel Injection....  Apotex Inc., c/o
                                                   Apotex Corp., 2400
                                                   North Commerce
                                                   Parkway, Suite 400,
                                                   Weston, FL 33326.
ANDA 040223............  Acetaminophen and        Barr Laboratories,
                          Codeine Phosphate        Inc., Subsidiary of
                          Tablets USP, 300 mg/15   Teva Pharmaceuticals
                          mg, 300 mg/30 mg, and    USA, Inc., 425 Privet
                          300 mg/60 mg.            Rd., Horsham, PA
                                                   19044.
ANDA 040297............  Estradiol Tablets USP,   Upsher-Smith
                          0.5 mg, 1 mg, and 2 mg.  Laboratories, Inc.,
                                                   6701 Evenstad Dr.,
                                                   Maple Grove, MN
                                                   55369.
ANDA 040311............  Medroxyprogesterone      Duramed
                          Acetate Tablets USP,     Pharmaceuticals,
                          2.5 mg, 5 mg, and 10     Inc., Subsidiary of
                          mg.                      Teva Pharmaceuticals
                                                   USA Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 040318............  Meperidine HCl Tablets   Do.
                          USP, 50 mg and 100 mg.
ANDA 040472............  Dextroamphetamine        Teva Pharmaceuticals
                          Saccharate,              USA, Inc., 425 Privet
                          Amphetamine Aspartate,   Rd., Horsham, PA
                          Dextroamphetamine        19044.
                          Sulfate, and
                          Amphetamine Sulfate
                          Tablets.
NDA 050143.............  Chloromycetin            Parkedale
                          (chloramphenicol         Pharmaceuticals,
                          ophthalmic solution      Inc., c/o King
                          USP) Ophthalmic          Pharmaceuticals,
                          Solution.                Inc., 501 Fifth St.,
                                                   Bristol, TN 37620.
NDA 050156.............  Chloromycetin            Do.
                          (chloramphenicol
                          ophthalmic ointment
                          USP) Ophthalmic
                          Ointment, 1%.
NDA 050443.............  Blenoxane (bleomycin     Bristol-Myers Squibb
                          sulfate) for             Co.
                          Injection, EQ 15 units
                          base/vial and 30 units
                          base/vial.
NDA 050630.............  Primaxin (imipenem and   Merck, Sharp & Dohme
                          cilastatin sodium)       Corp.
                          Powder, EQ 500 mg base/
                          vial; 500 mg/vial and
                          EQ 750 mg base/vial;
                          750 mg/vial.
ANDA 060306............  Penicillin G Potassium   Teva Pharmaceuticals
                          Tablets USP.             USA, Inc.
ANDA 060307............  Penicillin G Potassium   Do.
                          for Oral Solution USP.
ANDA 061969............  Cephalexin Capsules      Ivax Pharmaceuticals,
                          USP, EQ 250 mg base      Inc., Subsidiary of
                          and EQ 500 mg base.      Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062240............  Cloxacillin Sodium       Teva Pharmaceuticals
                          Capsules USP, EQ 250     USA, Inc.
                          mg base and EQ 500 mg
                          base.
ANDA 062252............  Oxacillin Sodium for     Teva Pharmaceuticals
                          Oral Solution USP, EQ    USA, Inc.
                          250 mg base/5 mL.
ANDA 062268............  Cloxacillin Sodium for   Do.
                          Oral Solution USP, EQ
                          125 mg base/5 mL.
ANDA 062653............  Doryx (doxycycline       Warner Chilcott Co.,
                          hyclate) Delayed-        LLC, c/o Warner
                          Release Capsules, EQ     Chilcott (US), LLC,
                          100 mg base.             100 Enterprise Dr.,
                                                   Rockaway, NJ 07866.
ANDA 062670............  Nystatin Oral            Teva Pharmaceuticals
                          Suspension USP,          USA, Inc.
                          100,000 units/mL.
ANDA 062683............  Cephradine Capsules      Do.
                          USP, 250 mg and 500 mg.
ANDA 062695............  Cefadroxil Capsules      Do.
                          USP, EQ 500 mg base.
ANDA 062751............  Erythromycin Pledgets    Ivax Pharmaceuticals,
                          USP, 2%.                 Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062760............  Cephalexin Capsules      Teva Pharmaceuticals
                          USP, EQ 250 mg base.     USA, Inc.
ANDA 062761............  Cephalexin Capsules      Do.
                          USP, EQ 500 mg base.
ANDA 062766............  Cefadroxil Capsules      Ivax Pharmaceuticals,
                          USP, EQ 500 mg base.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062767............  Cephalexin for Oral      Teva Pharmaceuticals
                          Suspension USP, EQ 125   USA, Inc.
                          mg base/5 mL.
ANDA 062768............  Cephalexin for Oral      Do.
                          Suspension USP, EQ 250
                          mg base/5 mL.
ANDA 062775............  Cephalexin Capsules      Barr Laboratories,
                          USP, EQ 500 mg base.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 062853............  Amoxicillin Capsules     Teva Pharmaceuticals
                          USP, 250 mg.             USA, Inc.
ANDA 062854............  Amoxicillin Capsules     Do.
                          USP, 500 mg.
ANDA 062946............  Amoxicillin for Oral     Do.
                          Suspension USP, 125 mg/
                          5 mL.
ANDA 063001............  Amoxicillin for Oral     Do.
                          Suspension USP, 250 mg/
                          5 mL.

[[Page 68429]]

 
ANDA 063018............  Cefazolin Sodium for     Do.
                          Injection USP, EQ 5
                          grams (g) base/vial
                          and EQ 10 g base/vial.
ANDA 063027............  Clindamycin HCl          Do.
                          Capsules USP, EQ 75 mg
                          base.
ANDA 063030............  Amoxicillin Capsules     Do.
                          USP, 250 mg.
ANDA 063031............  Amoxicillin Capsules     Do.
                          USP, 500 mg.
ANDA 064031............  Amoxicillin Chewable     Do.
                          Tablets, 125 mg and
                          250 mg.
ANDA 064081............  Cefaclor Capsules USP,   Do.
                          EQ 250 mg base and EQ
                          500 mg base.
ANDA 064145............  Cefaclor Capsules USP,   Do.
                          EQ 250 mg base and EQ
                          500 mg base.
ANDA 065137............  Clarithromycin Tablets   Ivax Pharmaceuticals,
                          USP, 250 mg and 500 mg.  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 070006............  Sulfamethoxazole and     Mutual Pharmaceutical
                          Trimethoprim Tablets     Co., Inc., 1100
                          USP, 400 mg/80 mg.       Orthodox St.,
                                                   Philadelphia, PA
                                                   19124.
ANDA 070007............  Sulfamethoxazole and     Do.
                          Trimethoprim Tablets
                          USP, 800 mg/160 mg.
ANDA 070232............  Propranolol HCl Tablets  Teva Pharmaceuticals
                          USP, 10 mg.              USA, Inc.
ANDA 070234............  Propranolol HCl Tablets  Do.
                          USP, 40 mg.
ANDA 070266............  Indo-Lemmon              Do.
                          (Indomethacin Capsules
                          USP), 25 mg.
ANDA 070267............  Indo-Lemmon              Do.
                          (Indomethacin Capsules
                          USP), 50 mg.
ANDA 070469............  Ibuprohn (Ibuprofen      Ohm Laboratories,
                          Tablets USP), 400 mg.    Inc., c/o Ranbaxy
                                                   Inc., 600 College Rd.
                                                   East, Princeton, NJ
                                                   08540.
ANDA 070618............  Potassium Chloride       Copley Pharmaceutical,
                          Extended-Release         Inc., Subsidiary of
                          Tablets USP, 8           Teva Pharmaceuticals
                          milliequivalents.        USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 070660............  Metoclopramide HCl       Mutual Pharmaceutical
                          Tablets USP, EQ 10 mg    Co., Inc.
                          base.
ANDA 071145............  Ibuprofen Tablets USP..  Ivax Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 071146............  Ibuprofen Tablets USP,   Do.
                          600 mg.
ANDA 071184............  Thiothixene HCl Oral     Teva Pharmaceuticals
                          Solution USP, EQ 5 mg    USA, Inc.
                          base/mL.
ANDA 071342............  Indomethacin Capsules    Do.
                          USP, 25 mg.
ANDA 071343............  Indomethacin Capsules    Do.
                          USP, 50 mg.
ANDA 072438............  Fenoprofen Calcium       Par Pharmaceutical,
                          Capsules USP, EQ 300     Inc., One Ram Ridge
                          mg base.                 Rd., Spring Valley,
                                                   NY 10977.
ANDA 072522............  Fluocinonide Topical     Teva Pharmaceuticals
                          Solution USP, 0.05%.     USA, Inc.
ANDA 072600............  Clofibrate Capsules      Do.
                          USP, 500 mg.
ANDA 072692............  Norethindrone and        Barr Laboratories,
                          Ethinyl Estradiol        Inc., Subsidiary of
                          Tablets USP, 0.5 mg/     Teva Pharmaceuticals,
                          0.035 mg.                USA, Inc.
ANDA 072999............  Dopamine HCl Injection   Teva Parenteral
                          USP, 200 mg/5 mL.        Medicines, Inc., 425
                                                   Privet Rd., Horsham,
                                                   PA 19044.
ANDA 073005............  Cinoxacin Capsules USP,  Teva Pharmaceuticals
                          250 mg.                  USA, Inc.
ANDA 073006............  Cinoxacin Capsules USP,  Do.
                          500 mg.
ANDA 073043............  Baclofen Tablets USP,    Do.
                          10 mg.
ANDA 073044............  Baclofen Tablets USP,    Do.
                          20 mg.
ANDA 073099............  Leucovorin Calcium       Pharmachemie B.V.,
                          Tablets USP, EQ 5 mg     Subsidiary of Teva
                          base.                    Pharmaceuticals USA,
                                                   Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 073101............  Leucovorin Calcium       Do.
                          Tablets USP, EQ 25 mg
                          base.
ANDA 073141............  Ibuprofen Tablets USP,   Teva Pharmaceuticals
                          200 mg.                  USA, Inc.
ANDA 073315............  Atenolol Tablets USP,    Do.
                          50 mg.
ANDA 073316............  Atenolol Tablets USP,    Do.
                          100 mg.
ANDA 073343............  Ibuprofen Tablets USP,   Do.
                          400 mg.
ANDA 073344............  Ibuprofen Tablets USP,   Do.
                          600 mg.
ANDA 073345............  Ibuprofen Tablets USP,   Do.
                          800 mg.
ANDA 073515............  Ketoprofen Capsules      Do.
                          USP, 25 mg.
ANDA 073679............  Diflunisal Tablets USP,  Do.
                          250 mg.
ANDA 074067............  Diltiazem HCl Tablets    Do.
                          USP, 30 mg, 60 mg, 90
                          mg, and 120 mg.
ANDA 074107............  Atenolol and             Pliva, Inc.,
                          Chlorthalidone Tablets   Subsidiary of Teva
                          USP, 50 mg/25 mg and     Pharmaceuticals USA,
                          100 mg/25 mg.            Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 074120............  Atenolol Tablets USP,    Teva Pharmaceuticals
                          50 mg and 100 mg.        USA, Inc.
ANDA 074123............  Pindolol Tablets USP, 5  G&W Laboratories,
                          mg and 10 mg.            Inc., 111 Coolidge
                                                   St., South
                                                   Plainfield, NJ 07080.
ANDA 074124............  Ciprofloxacin HCl        Barr Laboratories,
                          Tablets, EQ 250 mg       Inc., Subsidiary of
                          base, EQ 500 mg base,    Teva Pharmaceuticals
                          and EQ 750 mg base.      USA, Inc.
ANDA 074143............  Metoprolol Tartrate      Teva Pharmaceuticals
                          Tablets USP, 50 mg and   USA, Inc.
                          100 mg.
ANDA 074216............  Naproxen Tablets, 250    Do.
                          mg, 375 mg, and 500 mg.
ANDA 074294............  Alprazolam Tablets USP,  Ivax Pharmaceuticals,
                          0.25 mg, 0.5 mg, 1 mg,   Inc., Subsidiary of
                          and 2 mg.                Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074333............  Metoprolol Tartrate      Teva Pharmaceuticals
                          Tablets USP, 50 mg and   USA, Inc.
                          100 mg.
ANDA 074357............  Trazodone HCl Tablets    Do.
                          USP, 150 mg.
ANDA 074365............  Cimetidine Tablets USP,  Do.
                          200 mg, 300 mg, 400
                          mg, and 800 mg.

[[Page 68430]]

 
ANDA 074446............  Terazosin HCl Tablets,   Do.
                          EQ 1 mg base, EQ 2 mg
                          base, EQ 5 mg base,
                          and EQ 10 mg base.
ANDA 074459............  Diclofenac Sodium        Do.
                          Delayed-Release
                          Tablets USP, 25 mg, 50
                          mg, and 75 mg.
ANDA 074476............  Hydroxyurea Capsules     Roxane Laboratories,
                          USP, 500 mg.             Inc., 1809 Wilson
                                                   Rd., Columbus, OH
                                                   43228.
ANDA 074504............  Tamoxifen Citrate        Teva Pharmaceuticals
                          Tablets USP, EQ 10 mg    USA, Inc.
                          base and EQ 20 mg base.
ANDA 074537............  Selegiline HCl Tablets   G&W Laboratories, Inc.
                          USP, 5 mg.
ANDA 074555............  Cholestyramine for Oral  Teva Pharmaceuticals,
                          Suspension USP.          USA, Inc.
ANDA 074674............  Acyclovir Capsules USP,  Ivax Pharmaceuticals,
                          200 mg.                  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074745............  Megestrol Acetate        Teva Pharmaceuticals
                          Tablets USP, 40 mg.      USA, Inc.
ANDA 074771............  Cholestyramine for Oral  Do.
                          Suspension USP.
ANDA 074847............  Etodolac Tablets USP,    Do.
                          400 mg and 500 mg.
ANDA 074883............  Etodolac Tablets USP,    Ivax Pharmaceuticals,
                          400 mg and 500 mg.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 074895............  Amiodarone HCl Tablets,  Teva Pharmaceuticals
                          200 mg.                  USA, Inc.
ANDA 074914............  Acyclovir Capsules USP,  Do.
                          200 mg.
ANDA 074989............  Labetalol HCl Tablets    Do.
                          USP, 100 mg, 200 mg,
                          and 300 mg.
ANDA 075021............  Acyclovir Tablets USP,   Do.
                          400 mg and 800 mg.
ANDA 075557............  Ranitidine HCl           Do.
                          Capsules, EQ 150 mg
                          base and EQ 300 mg
                          base.
ANDA 075686............  Bisoprolol Fumarate and  Do.
                          Hydrochlorothiazide
                          Tablets USP, 2.5 mg/
                          6.25 mg, 5 mg/6.25 mg,
                          and 10 mg/6.25 mg.
ANDA 075719............  Sertraline HCl Tablets   Do.
                          USP, EQ 25 mg base, EQ
                          50 mg base, and EQ 100
                          mg base.
ANDA 075726............  Pemoline Tablets, 18.75  Mallinckrodt Inc., 675
                          mg, 37.5 mg, and 75 mg.  McConnell Blvd.,
                                                   Hazelwood, MO 63042.
ANDA 075740............  Tamoxifen Citrate        Ivax Pharmaceuticals,
                          Tablets USP, EQ 10 mg    Inc., Subsidiary of
                          base and EQ 20 mg base.  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075810............  Fluoxetine HCl Tablets   Barr Laboratories,
                          , EQ 10 mg base.         Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075823............  Calcitriol Injection     Teva Parenteral
                          USP, 0.001 mg/mL and     Medicines, Inc.
                          0.002 mg/mL.
ANDA 075827............  Gabapentin Tablets USP,  Teva Pharmaceuticals
                          600 mg and 800 mg.       USA, Inc.
ANDA 075862............  Levonorgestrel and       Barr Laboratories,
                          Ethinyl Estradiol        Inc., Subsidiary of
                          Tablets USP, 0.1 mg/     Teva Pharmaceuticals
                          0.02 mg.                 USA, Inc.
ANDA 075865............  Fluoxetine HCl Tablets   Ivax Pharmaceuticals,
                          , EQ 10 mg base and EQ   Inc., Subsidiary of
                          40 mg base.              Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075971............  Metformin HCl Tablets    Barr Laboratories,
                          USP, 500 mg, 850 mg,     Inc., Subsidiary of
                          and 1 g.                 Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 075975............  Metformin HCl Tablets    Ivax Pharmaceuticals,
                          USP, 500 mg, 625 mg,     Inc., Subsidiary of
                          750 mg, 850 mg, and 1    Teva Pharmaceuticals
                          g.                       USA, Inc.
ANDA 076094............  Pergolide Mesylate       Do.
                          Tablets, EQ 0.05 mg
                          base, EQ 0.25 mg base,
                          and EQ 1 mg base.
ANDA 076184............  Alendronate Sodium       Teva Pharmaceuticals
                          Tablets USP, EQ 35 mg    USA, Inc.
                          tablets and EQ 70 mg
                          tablets.
ANDA 076198............  Balziva-21 Tablets       Barr Laboratories,
                          (norethindrone and       Inc., Subsidiary of
                          ethinyl estradiol        Teva Pharmaceuticals
                          tablets USP), 0.4 mg/    USA, Inc.
                          0.035 mg.
ANDA 076244............  Mirtazapine Tablets      Ivax Pharmaceuticals,
                          USP, 15 mg, 30 mg, and   Inc., Subsidiary of
                          45 mg.                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076251............  Fluoxetine HCl           Barr Laboratories,
                          Capsules, EQ 40 mg       Inc., Subsidiary of
                          base.                    Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076328............  Metformin HCl Tablets    Teva Pharmaceuticals
                          USP, 500 mg, 850 mg,     USA, Inc.
                          and 1 g.
ANDA 076340............  Finasteride Tablets      Ivax Pharmaceuticals,
                          USP, 5 mg.               Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076426............  Ciprofloxacin HCl        Pliva, Inc.,
                          Tablets , EQ 100 mg      Subsidiary of Teva
                          base, EQ 250 mg base,    Pharmaceuticals USA,
                          EQ 500 mg base, and EQ   Inc.
                          750 mg base.
ANDA 076496............  Metformin HCl Extended-  Barr Pharmaceuticals,
                          Release Tablets USP,     Inc., Subsidiary of
                          500 mg.                  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076545............  Metformin HCl Extended-  Ivax Pharmaceuticals,
                          Release Tablets USP,     Inc., Subsidiary of
                          500 mg.                  Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076840............  Sumatriptan Succinate    Teva Pharmaceuticals
                          Tablets, EQ 25 mg        USA, Inc.
                          base, EQ 50 mg base,
                          and EQ 100 mg base.
ANDA 076880............  Nicotine Polacrilex Gum  Ivax Pharmaceuticals,
                          USP, EQ 2 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 076945............  Fosinopril Sodium and    Teva Pharmaceuticals
                          Hydrochlorothiazide      USA, Inc.
                          Tablets USP, 10 mg/
                          12.5 mg and 20 mg/12.5
                          mg.
ANDA 077020............  Cilostazol Tablets USP,  Ivax Pharmaceuticals,
                          100 mg.                  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 077082............  Paroxetine Tablets USP,  Teva Pharmaceuticals
                          EQ 10 mg base, EQ 20     USA, Inc.
                          mg base, EQ 30 mg
                          base, and EQ 40 mg
                          base.

[[Page 68431]]

 
ANDA 077775............  Fentanyl Extended-       Noven,
                          Release Film, 25         Pharmaceuticals, Inc.
                          micrograms (mcg), 50
                          mcg, 75 mcg, and 100
                          mcg.
ANDA 077850............  Nicotine Polacrilex Gum  Ivax Pharmaceuticals,
                          USP, EQ 4 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 077898............  Cilostazol Tablets USP,  Pliva Hrvatska DOO, c/
                          50 mg and 100 mg.        o Teva
                                                   Pharmaceuticals USA,
                                                   Inc.,425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 077973............  Bicalutamide Tablets     Synthon
                          USP, 50 mg.              Pharmaceuticals,
                                                   Inc., 9000
                                                   Development Dr., P.O.
                                                   Box 110487, Research
                                                   Triangle Park, NC
                                                   27709.
ANDA 077995............  Bicalutamide Tablets     Kudco Ireland Limited,
                          UPS, 50 mg.              c/o Kremers Urban
                                                   Pharmaceuticals,
                                                   Inc., 1101 C Ave.
                                                   West, Seymour, IN
                                                   47274.
ANDA 078079............  Ciclopirox Topical       Teva Pharmaceuticals
                          Solution USP, 8%.        USA, Inc.
ANDA 078221............  Granisetron HCl Tablets  Barr Laboratories,
                          USP, EQ 1 mg base.       Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 078263............  Perindopril Erbumine     Lupin Limited, c/o
                          Tablets, 2 mg, 4 mg,     Lupin
                          and 8 mg.                Pharmaceuticals,
                                                   Inc., 111 South
                                                   Calvert St.,
                                                   Harborplace Tower,
                                                   21st Floor,
                                                   Baltimore, MD 21202.
ANDA 078567............  Ciclopirox Topical       Mylan Pharmaceuticals
                          Solution USP, 8%.        Inc., 781 Chestnut
                                                   Ridge Rd., P.O. Box
                                                   4310, Morgantown, WV
                                                   26504.
ANDA 078666............  Levonorgestrel Tablets,  Watson Laboratories,
                          0.75 mg.                 Inc., 311 Bonnie
                                                   Circle, Corona, CA
                                                   92880.
ANDA 078773............  Atorvastatin Calcium     Teva Pharmaceuticals
                          Tablets, EQ 10 mg        USA, Inc.
                          base, EQ 20 mg (base),
                          EQ 40 mg base, and EQ
                          80 mg base.
ANDA 080400............  Hydrocortisone Cream     Do.
                          USP.
ANDA 080828............  Hydrocortisone Acetate   Fera Pharmaceuticals
                          Ophthalmic Ointment      LLC, 134 Birch Hill
                          USP, 0.5%.               Rd., Locust Valley,
                                                   NY 11560.
ANDA 083919............  Meprobamate Tablets      Meda Pharmaceuticals
                          USP, 600 mg.             Inc., 265 Davidson
                                                   Ave., Suite 400,
                                                   Somerset, NJ 08873.
ANDA 085022............  Hydrochlorothiazide      Ivax Pharmaceuticals,
                          Tablets USP, 100 mg.     Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 085855............  A-Methapred              Hospira, Inc.
                          (methylprednisolone
                          sodium succinate for
                          Injection USP), EQ 125
                          mg base/vial.
ANDA 086750............  Ergotamine Tartrate      Organon USA, Inc.
                          Sublingual Tablets
                          USP, 2 mg.
ANDA 087014............  Orgatrax (hydroxyzine    Do.
                          HCl Injection USP), 25
                          mg/mL and 50 mg/mL.
ANDA 087264............  Thioridazine HCl         Mutual Pharmaceutical
                          Tablets USP, 25 mg.      Co., Inc.
ANDA 087665............  Sulfinpyrazone Tablets   Barr Pharmaceuticals,
                          USP, 100 mg.             Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087666............  Sulfinpyrazone Capsules  Do.
                          USP, 200 mg.
ANDA 087760............  Hydroxyzine Pamoate      Ivax Pharmaceuticals,
                          Capsules USP, EQ 50 mg   Inc., Subsidiary of
                          HCl.                     Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 087761............  Hydroxyzine Pamoate      Do.
                          Capsules USP, EQ 25 mg
                          HCl.
ANDA 088370............  Thioridazine HCl         Mutual Pharmaceutical
                          Tablets USP, 50 mg.      Co., Inc.
ANDA 088375............  Thioridazine HCl         Do.
                          Tablets USP, 10 mg.
ANDA 088379............  Thioridazine HCl         Do.
                          Tablets USP, 100 mg.
ANDA 088469............  Dexamethasone Sodium     Fresenius Kabi USA,
                          Phosphate Injection      LLC.
                          USP, EQ 10 mg
                          Phosphate/mL.
ANDA 088900............  Doxylamine Succinate     Copley
                          Tablets USP, 25 mg.      Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 088902............  Chlorthalidone Tablets   Barr Laboratories,
                          USP, 25 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 088903............  Chlorthalidone Tablets   Do.
                          USP, 50 mg.
ANDA 088974............  Procainamide HCl         ANI Pharmaceuticals,
                          Extended-Release         Inc.,.
                          Tablets USP, 500 mg.
ANDA 089109............  Promethazine HCl         Teva Pharmaceuticals
                          Tablets USP, 25 mg.      USA, Inc.
ANDA 090299............  Melphalan HCl for        Mylan Institutional
                          Injection, EQ 50 mg      LLC, 4901 Hiawatha
                          base/vial.               Dr., Rockford, IL
                                                   61103.
ANDA 090924............  Ibutilide Fumarate       Do.
                          Injection, 0.1 mg/mL.
ANDA 091242............  Anastrozole Tablets      Impax Laboratories,
                          USP, 1 mg.               Inc., 30831 Huntwood
                                                   Ave., Hayward, CA
                                                   94544.
ANDA 091638............  Letrozole Tablets USP,   Do.
                          2.5 mg.
ANDA 200792............  Oxymorphone HCl          Par Pharmaceutical,
                          Extended-Release         Inc.
                          Tablets, 5 mg, 7.5 mg,
                          10 mg, 15 mg, 20 mg,
                          30 mg, and 40 mg.
ANDA 204538............  Zidovudine Injection     Liaoning Chengda
                          USP, 10 mg/mL.           Biotechnology Co.,
                                                   Ltd., c/o Ruby
                                                   Pharma, Inc., 116
                                                   Village Blvd, Suite
                                                   200, Princeton, NJ
                                                   08540.
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner, approval of the applications listed in table 1 in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective November 3, 2016. Introduction or delivery for 
introduction into interstate

[[Page 68432]]

commerce of products without approved new drug applications violates 
section 301(a) and (d) of the FD&C 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: September 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23893 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P