Document ID: FDA-2013-N-0845-0001
Agency: fda
Document Type: Notice
Title: Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications
Posted Date: 2013-07-19T04:00Z

[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43210-43214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17324]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0845]

Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug 
Applications and 77 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 52 new drug applications (NDAs) and 77 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be withdrawn.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 August 19, 2013.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in

[[Page 43211]]

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 011620.................  Cardiografin           Bracco Diagnostics,
                              (diatrizoate           107 College Rd.
                              meglumine USP, 85%)    East, Princeton, NJ
                              Injection.             08540.
NDA 012828.................  Travase (sutilains)    Abbott Laboratories,
                              Ointment.              PA 77/Bldg. AP30-
                                                     1E, 200 Abbott Park
                                                     Rd., Abbott Park,
                                                     IL 60064-6157.
NDA 014215.................  Celestone              Merck Sharp & Dohme
                              (betamethasone) Oral   Corp., One Merck
                              Solution.              Dr., P.O. Box 100,
                                                     Whitehouse Station,
                                                     NJ 08889.
NDA 014685.................  Aventyl                Ranbaxy Inc., U.S.
                              (nortriptyline         Agent for Ranbaxy
                              hydrochloride (HCl)    Laboratories
                              Oral Solution, 10      Limited, 600
                              milligrams (mg)/5      College Rd. East,
                              milliliters (mL).      Princeton, NJ
                                                     08540.
NDA 014860.................  Aralen Phosphate       Sanofi-Aventis U.S.,
                              (chloroquine           LLC, 55 Corporate
                              phosphate) with        Dr., Bridgewater,
                              primaquine phosphate   NJ 08807-0890.
                              Tablets.
NDA 016017.................  Cloroquine-Primaquine  Do.
                              (chloroquine
                              phosphate and
                              primaquine
                              phosphate) Tablets.
NDA 016019.................  Questran Resin         Bristol-Myers Squibb
                              (cholestyramine        Co., P.O. Box 4000,
                              resin).                Princeton, NJ 08543-
                                                     4000.
NDA 016640.................  Questran Powder        Do.
                              (cholestyramine for
                              oral suspension).
NDA 016721.................  Dalmane (flurazepam    Valeant
                              HCl) Capsules.         Pharmaceuticals
                                                     North America, LLC,
                                                     700 Route 202/206
                                                     North, Bridgewater,
                                                     NJ 08807.
NDA 016732.................  Talwin 50              Sanofi-Aventis U.S.,
                              (pentazocine HCl       LLC.
                              USP), Tablets, 50 mg.
NDA 016891.................  Talwin Compound        Do.
                              (pentazocine HCl USP
                              and aspirin USP),
                              Equivalent to (EQ)
                              12.5 mg (base) and
                              325 mg.
NDA 016927.................  Demulen 1/50-21        G.D. Searle, LLC, c/
                              (ethynodiol            o Pfizer Inc., 235
                              diacetate/ethinyl      East 42nd St., New
                              estradiol) Tablets.    York, NY 10017.
NDA 016936.................  Demulen 1/50-28        Do.
                              (ethynodiol
                              diacetate/ethinyl
                              estradiol) Tablets.
NDA 017557.................  Danocrine (danazol)    Sanofi-Aventis U.S.,
                              Capsules.              LLC.
NDA 017633.................  Glycine Irrigation     Hospira, Inc., 275
                              USP, 1.5%.             North Field Dr.,
                                                     Lake Forest, IL
                                                     60045.
NDA 017821.................  Flexeril               Janssen Research &
                              (cyclobenzaprine       Development, LLC,
                              HCl) Tablets, 5 mg     1125 Trenton-
                              and 10 mg.             Harbourton Rd.,
                                                     Titusville, NJ
                                                     08560.
NDA 017850.................  Klotrix (potassium     Bristol-Myers Squibb
                              chloride) Extended-    Co.
                              Release Tablets.
NDA 017857.................  Stadol (butorphanol    Do.
                              tartrate USP)
                              Injection.
NDA 018160.................  Demulen 1/35-28        G.D. Searle, LLC, c/
                              (ethynodiol            o Pfizer Inc.
                              diacetate/ethinyl
                              estradiol) Tablets.
NDA 018168.................  Demulen 1/35-21        Do.
                              (ethynodiol
                              diacetate/ethinyl
                              estradiol) Tablets.
ANDA 018398................  Dopamine HCl           Baxter Healthcare
                              Injection USP, 40 mg/  Corp., 25212 W.
                              mL and 80 mg/mL.       Illinois Route 120,
                                                     Round Lake, IL
                                                     60073.
NDA 018458.................  Talacen (pentazocine   Sanofi-Aventis U.S.,
                              HCl USP and            LLC.
                              acetaminophen USP),
                              Tablets, EQ 25 mg
                              (base) and 650 mg.
ANDA 018581................  Sodium Nitroprusside   Baxter Healthcare
                              for Injection USP,     Corp.
                              50 mg/vial.
NDA 018733.................  Talwin Nx              Sanofi-Aventis U.S.,
                              (pentazocine HCl and   LLC.
                              naloxone HCl)
                              Tablets, 50 mg and
                              0.5 mg.
NDA 018981.................  Enkaid (encainide      Bristol-Myers Squibb
                              HCl) Capsules.         Co.
NDA 019057.................  Hytrin (terazosin      Abbott Laboratories.
                              HCl) Tablets, 1 mg,
                              2 mg, 5 mg, and 10
                              mg.
NDA 019436.................  Primacor (milrinone    Sanofi-Aventis U.S.,
                              lactate) Injection,    LLC.
                              EQ 1 mg (base)/mL.
NDA 019507.................  Kerlone (betaxolol     Do.
                              HCl) Tablets, 10 mg
                              and 20 mg.
NDA 019578.................  Mefloquine HCl         U.S. Army Office of
                              Tablets, 250 mg.       the Surgeon
                                                     General, Department
                                                     of the Army, 1430
                                                     Veterans Dr., Fort
                                                     Detrick, MD 21702-
                                                     5009.
NDA 019669.................  Questran Light,        Bristol-Myers Squibb
                              Questran II, and       Co.
                              Questran Sugar Free
                              (cholestyramine for
                              oral suspension).
NDA 019807.................  Kerledex (betaxolol    Sanofi-Aventis U.S.,
                              HCl and                LLC.
                              chlorthalidone)
                              Tablets.
NDA 019977.................  Oramorph SR (morphine  Xanodyne
                              sulfate) Sustained-    Pharmaceuticals,
                              Release Tablets, 15    Inc., One
                              mg, 30 mg, 60 mg,      Riverfront Pl.,
                              and 100 mg.            Newport, KY 41071.
NDA 020036.................  Aredia (pamidronate    Novartis
                              disodium) for          Pharmacueticals
                              injection, 30 mg, 60   Corp., One Health
                              mg, and 90 mg.         Plaza, East
                                                     Hanover, NJ 07936-
                                                     1080.
NDA 020038.................  Fludara (fludarabine   Genzyme Corp., 500
                              phosphate) for         Kendall St.,
                              Injection, 50 mg/      Cambridge, MA
                              vial.                  02142.
NDA 020056.................  Atropine Sulfate       U.S. Army Office of
                              Aerosol for            the Surgeon
                              Inhalation.            General.
NDA 020070.................  Cognex (tacrine HCl)   Shionogi Inc., 300
                              Capsules, 10 mg, 20    Campus Dr., Florham
                              mg, 30 mg, and 40 mg.  Park, NJ 07932.
NDA 020095.................  Zantac (ranitidine     GlaxoSmithKline,
                              HCl) Geldose           P.O. Box 13398, 5
                              Capsules.              Moore Dr., Research
                                                     Triangle Park, NC
                                                     27709.
NDA 020151.................  Effexor (venlafaxine   Wyeth
                              HCl) Tablets, 12.5     Pharmaceuticals,
                              mg, 25 mg, 37.5 mg,    Inc., 235 East 42nd
                              50 mg, 75 mg, and      St., New York, NY
                              100 mg.                10017.
NDA 020239.................  Kytril (granisetron    Hoffman-La Roche,
                              HCl) Injection, EQ 1   Inc., c/o
                              mg (base)/mL and 0.1   Genentech, Inc., 1
                              mg (base)/mL, 1 mg     DNA Way, South San
                              (base)/mL, and 3 mg    Francisco, CA
                              (base)/mL.             94080.

[[Page 43212]]

 
NDA 020305.................  Kytril (granisetron    Do.
                              HCl) Tablets, EQ 1
                              mg (base), EQ 2 mg
                              (base).
NDA 020336.................  DynaCirc CR            GlaxoSmithKline,
                              (isradipine)           2301 Renaissance
                              Controlled-Release     Blvd., King of
                              Tablets.               Prussia, PA 19406.
NDA 020343.................  Primacor (milrinone    Sanofi-Aventis U.S.,
                              lactate) Injection.    LLC.
NDA 020347.................  Hytrin (terazosin      Abbott Laboratories.
                              HCl) Capsules, 1 mg,
                              2 mg, 5, mg, and 10
                              mg.
NDA 020441.................  Pulmicort Turbuhaler   AstraZeneca, 1800
                              (budesonide)           Concord Pike, P.O.
                              Inhalation Powder.     Box 8355,
                                                     Wilmington, DE
                                                     19803-8355.
NDA 020484.................  Innohep (tinzaparin    LEO Pharma A/S, c/o
                              sodium) Injection.     Parexel
                                                     International
                                                     Corp., 4600 East-
                                                     West Highway, Suite
                                                     350, Bethesda, MD
                                                     20814.
NDA 020611.................  Dovonex                LEO Pharma A/S, c/o
                              (calcipotriene)        LEO Pharma Inc., 1
                              Topical Solution,      Sylvan Way,
                              0.005%.                Parsippany, NJ
                                                     07054.
NDA 020680.................  Norvir (ritonavir)     Abbott Laboratories.
                              Capsules, 100 mg.
NDA 021238.................  Kytril (granisetron    Hoffman-La Roche,
                              HCl) Oral Solution,    Inc., c/o
                              2 mg/10 mL.            Genentech, Inc.
NDA 021320.................  Plenaxis (abarelix)    Specialty European
                              Injection, 100 mg/     Pharma Limited, c/o
                              vial.                  Strategic
                                                     Bioscience Corp.,
                                                     93 Birch Hill Rd.,
                                                     Stow, MA 01775.
NDA 021744.................  Proquin XR             Depomed Inc., 1360
                              (ciprofloxacin HCl)    O'Brien Dr., Menlo
                              Tablets, 500 mg.       Park, CA 94025.
NDA 022021.................  Altace (ramipril)      King Pharmaceuticals
                              Tablets, 1.25 mg,      Inc., c/o Pfizer
                              2.5 mg, 5 mg, and 10   Inc., 235 East 42nd
                              mg.                    St., New York, NY
                                                     10017.
NDA 022026.................  Amlodipine Besylate    Synthon
                              Orally                 Pharmaceuticals,
                              Disintegrating         Inc., 9000
                              Tablets, 2.5 mg, 5     Development Dr.,
                              mg, and 10 mg.         P.O. Box 110487,
                                                     Research Triangle
                                                     Park, NC 27709.
NDA 022456.................  Omeprazole, Sodium     Santarus, Inc., 3721
                              Bicarbonate, and       Valley Centre Dr.,
                              Magnesium Hydroxide    Suite 400, San
                              Tablets.               Diego, CA 92130.
ANDA 040015................  Neosar                 Teva Parenteral
                              (cyclophosphamide)     Medicines, Inc., 19
                              for Injection, 100     Hughes, Irvine, CA
                              mg, 200 mg, 500 mg,    92618.
                              1 gram (gm), and 2
                              gm vials.
ANDA 040079................  Thiamine HCl           Hospira, Inc.
                              Injection USP, 100
                              mg/mL.
ANDA 040131................  Edrophonium Chloride   Do.
                              Injection, 10 mg/mL.
ANDA 040162................  Prochlorperazine       IVAX
                              Maleate Tablets USP,   Pharmaceuticals,
                              5 mg and 10 mg.        Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 040272................  Oxycodone and          Duramed
                              Acetaminophen          Pharmaceuticals,
                              Tablets USP, 5 mg/     Inc., Subsidiary of
                              325 mg.                Barr Laboratories,
                                                     Inc., Indirect
                                                     Wholly Owned
                                                     Subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 040332................  Leucovorin Calcium     Teva Parenteral
                              Injection USP, 10 mg   Medicines, Inc.
                              (base).
ANDA 040364................  Prednisolone Syrup,    Nesher
                              15 mg/5 mL.            Pharmaceuticals
                                                     (USA) LLC, 13910
                                                     Saint Charles Rock
                                                     Rd., Bridgton, MO
                                                     63044.
ANDA 040373................  Hydralazine HCl        Teva Parenteral
                              Injection USP, 20 mg/  Medicines, Inc.
                              mL.
ANDA 040423................  Prednisolone Syrup, 5  Nesher
                              mg/5 mL.               Pharmaceuticals
                                                     (USA) LLC.
ANDA 040505................  Prochlorperazine       Teva Parenteral
                              Edisylate Injection    Medicines, Inc.
                              USP, 5 mg/mL.
ANDA 040641................  Methylprednisolone     Bedford
                              Sodium Succinate for   Laboratories, 300
                              Injection USP, 125     Northfield Rd.,
                              mg/vial, 500 mg/       Bedford, OH 44146.
                              vial, and 1 gm/vial.
ANDA 040662................  Methylprednisolone     Do.
                              Sodium Succinate for
                              Injection USP, 40 mg/
                              vial.
ANDA 040709................  Methylprednisolone     Do.
                              Sodium Succinate for
                              Injection USP, 500
                              mg/vial and 1 gm/
                              vial.
ANDA 040795................  Benzonatate Capsules   Nesher
                              USP, 100 mg and 200    Pharmaceuticals
                              mg.                    (USA) LLC.
ANDA 040909................  Sodium Polystyrene     Citrus Pharma, LLC,
                              Sulfonate Powder for   3940 Quebec Ave.
                              Suspension, 454 gm/    North, Minneapolis,
                              bottle.                MN 55427.
NDA 050261.................  Declomycin             CorePharma, LLC, 215
                              (demeclocycline HCl)   Wood Ave.,
                              Tablets, 75 mg, 150    Middllesex, NJ
                              mg, and 300 mg.        08846-2554.
ANDA 060003................  V-Cillin K (pencillin  Eli Lilly and Co.,
                              V potassium tablets    Lilly Corporate
                              USP), 125 mg, 250      Center,
                              mg, and 500 mg.        Indianapolis, IN
                                                     46285.
ANDA 060517................  Fugizone               Bristol-Myers Squibb
                              (amphotericin B) for   Co.
                              Injection.
ANDA 060575................  Mycostatin (nystatin)  Do.
                              Cream, 100,000 units/
                              gm.
ANDA 061901................  Kantrex (kanamycin     Sandoz Inc., 2555 W.
                              sulfate injection      Midway Blvd.,
                              USP) Injection,75 mg/  Broomfield, CO
                              2 mL, 500 mg/2 mL,     80038-0446.
                              and 1 gm/3 mL.
ANDA 062008................  Nebcin (tobramycin     Eli Lilly and Co.
                              for injection USP).
ANDA 062311................  Amikin (amikacin       Brisol-Myers Squibb
                              sulfate injection      Co.
                              USP), 50 mg/mL and
                              250 mg/mL.
ANDA 062707................  Nebcin (tobramycin     Eli Lilly and Co.
                              for injection USP).
ANDA 063041................  Clindamycin Injection  Teva Parenteral
                              USP.                   Medicines, Inc.
ANDA 063080................  Tobramycin Injection   Hospira, Inc.
                              USP.
ANDA 063149................  Gentamicin Injection   Teva Parenteral
                              USP, 10 mg/mL.         Medicines, Inc.
ANDA 063282................  Clindamycin Phosphate  Do.
                              Injection, EQ 150 mg
                              (base)/mL.
ANDA 063253................  Erythromycin           Do.
                              Lactobionate for
                              Injection USP, 500
                              mg (base)/vial and 1
                              gm (base)/vial.
ANDA 064021................  Tobramycin Sulfate     Bristol-Myers Squibb
                              Injection.             Co.
                             Amphotericin B for     Teva Parenteral
                              Injection USP, 50 mg/  Medicines, Inc.
                              vial.
ANDA 064212................  Daunorubicin HCl for   Do.
                              Injection USP, 20 mg
                              (base)/vial and 50
                              mg (base)/vial.

[[Page 43213]]

 
ANDA 065037................  Idarubicin HCl for     Do.
                              Injection USP, 5 mg/
                              vial, 10 mg/vial,
                              and 20 mg/vial.
ANDA 065321................  Nystatin Topical       Nesher
                              Powder USP, 100,000    Pharmaceuticals
                              units/gm.              (USA) LLC.
ANDA 065433................  Mycophenolate Mofetil  Zydus
                              Capsules, 250 mg.      Pharmaceuticals
                                                     (USA) Inc., 73
                                                     Route 31 North,
                                                     Pennington, NJ
                                                     08534.
ANDA 065477................  Mycophenolate Mofetil  Do.
                              Tablets, 500 mg.
ANDA 070159................  Tolazamide Tablets     Par Pharmaceutical,
                              USP, 100 mg.           Inc., One Ram Ridge
                                                     Rd., Spring Valley,
                                                     NY 10977.
ANDA 070160................  Tolazamide Tablets     Do.
                              USP, 250 mg.
ANDA 070161................  Tolazamide Tablets     Do.
                              USP, 500 mg.
ANDA 070431................  Valproic Acid          Do.
                              Capsules, 250 mg.
ANDA 070577................  Verapamil HCl          Hospira, Inc.
                              Injection USP, 2.5
                              mg/mL.
ANDA 070818................  Ibuprofen Tablets      Ohm Laboratories, c/
                              USP, 400 mg.           o Ranbaxy Inc., 600
                                                     College Rd. East,
                                                     Princeton, NJ
                                                     08540.
ANDA 070980................  Potassium Chloride     Nesher
                              Extended-Release       Pharmaceuticals
                              Capsules USP, 10       (USA) LLC.
                              milliequivalents.
ANDA 071200................  Disopyramide           Do.
                              Phosphate Extended-
                              Release Capsules
                              USP, 150 mg.
ANDA 071726................  Metaproterenol         Nephron
                              Sulfate Inhalation     Pharmaceuticals
                              Solution, 0.6%.        Corp., 4121 South
                                                     West 34th St.,
                                                     Orlando, FL 32811.
ANDA 071855................  Metaproterenol         Do.
                              Sulfate Inhalation
                              Solution, 0.4%.
ANDA 072273................  Albuterol Inhalation   Armstrong
                              Aerosol\1\.            Pharmaceuticals,
                                                     Inc. 25 John Rd.,
                                                     Canton, MA 02021.
ANDA 072437................  Fenoprofen Calcium     Par Pharmaceuticals,
                              Capsules USP, 200 mg.  Inc.
ANDA 072974................  Methyldopate HCl       Teva Parenteral
                              Injection USP.         Medicines, Inc.
ANDA 073000................  Dopamine HCl           Do.
                              Injection USP, 80 mg/
                              mL.
ANDA 073117................  Metoclopramine         Hospira, Inc.
                              Injection USP, 5 mg/
                              mL.
ANDA 073465................  Sodium Nitroprusside   Teva Parenteral
                              Injection, 25 mg/mL.   Medicines, Inc.
ANDA 073617................  Pentamidine            Baxter Healthcare
                              Isethionate for        Corp.
                              Injection, 300 mg/
                              vial.
ANDA 073683................  Cyclobenzaprine HCl    Sandoz Inc.
                              Tablets, 10 mg.
ANDA 074013................  Pindolol Tablets USP,  Mylan
                              5 mg.                  Pharmaceuticals,
                                                     Inc., 781 Chestnut
                                                     Ridge Rd., P.O. Box
                                                     4310, Morgantown,
                                                     WV 26505-4310.
ANDA 074018................  Pindolol Tablets USP,  Do.
                              10 mg.
ANDA 074105................  Naproxen Tablets USP,  DAVA
                              250 mg, 375 mg, and    Pharmaceuticals,
                              500 mg.                Inc., Parker Plaza,
                                                     400 Kelby St., 10th
                                                     Floor, Fort Lee, NJ
                                                     07024.
ANDA 074147................  Metoclopramide         Hospira, Inc.
                              Injection USP, 5 mg/
                              mL.
ANDA 074206................  Dobutamine Injection   Teva Parenteral
                              USP, 250 mg (base)/    Medicines, Inc.
                              20 mL.
ANDA 074252................  Cimetidine HCl         Do.
                              Injection, EQ 300 mg
                              (base)/2 mL.
ANDA 074519................  Captopril Tablets,     Sandoz Inc.
                              12.5 mg, 25 mg, 50
                              mg, and 100 mg.
ANDA 074613................  Bumetanide Injection   Teva Parenteral
                              USP, 0.25 mg/mL.       Medicines, Inc.
ANDA 074616................  Inamrinone Lactate     Hospira, Inc.
                              Injection, 5 mg/mL.
ANDA 074629................  Iopamidol Injection    Baxter Healthcare
                              USP, 41%, 51%, 61%,    Corp.
                              and 76%.
ANDA 074637................  Iopamidol Injection    Hospira, Inc.
                              USP, 61%.
ANDA 074753................  Atracurium Besylate    Baxter Healthcare
                              Injection USP, 10 mg/  Corp.
                              mL (preserved).
ANDA 074768................  Atracurium Besylate    Do.
                              Injection USP, 10 mg/
                              mL (preservative
                              free).
ANDA 074784................  Atracurium Besylate    Teva Parenteral
                              Injection USP, 10 mg/  Medicines, Inc.
                              mL.
ANDA 074795................  Fluphenazine           Do.
                              Decanoate Injection
                              USP, 25 mg/mL.
ANDA 074969................  Acyclovir for          Do.
                              Injection USP, 500
                              mg/vial and 1,000 mg/
                              vial.
ANDA 075004................  Diltiazem HCl          Hospira, Inc.
                              Injection, 5 mg/mL.
ANDA 075005................  Iopamidol Injection    Do.
                              USP, 51%, 61%, and
                              76%.
ANDA 075012................  Etodolac Tablets USP,  Mylan
                              400 mg and 500 mg.     Pharmaceuticals,
                                                     Inc.
ANDA 075071................  Etodolac Capsules,     Do.
                              200 mg and 300 mg.
ANDA 075119................  Buspirone HCl Tablet   Egis Pharmaceuticals
                              USP, 5 mg, 10 mg,      PLC, c/o GlobePharm
                              and 15 mg.             Inc., 313 Pine St.,
                                                     Suite 204,
                                                     Deerfield, IL
                                                     60015.
NDA 075166.................  Isosorbide             SkyePharma AG, c/o
                              Mononitrate Extended-  Compliance
                              Release Tablets, 60    Resources, LLC,
                              mg.                    7100 Farmington
                                                     Lane, Hillsborough,
                                                     NC 27278.
ANDA 075328................  Pemoline Tablets,      Vintage
                              18.75 mg, 37.5 mg,     Pharmaceuticals,
                              and 75 mg.             120 Vintage Dr.,
                                                     Huntsville, AL
                                                     35811.
ANDA 075392................  Propofol Injectable    Teva Parenteral
                              Emulsion, 10 mg/mL.    Medicines, Inc.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any albuterol metered-dose inhalers
  (see 70 FR 17168, April 4, 2005).

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (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 August 19, 2013. Introduction or delivery for 
introduction into interstate 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

[[Page 43214]]

DATES) 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: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P