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Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 70 new drug applications (NDAs) and 97 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective Date: July 8, 2011.

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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.

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The holders of the applications listed in table 1 of 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 § 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 § 314.150(c) is without prejudice to refiling.

Table 1

Application No.DrugApplicant
NDA 007289Trigesic and Trigesic with Codeine TabletsBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 008248Wyamine (mephentermine sulfate) Sulfate InjectionBaxter Healthcare Corp., 2 Esterbrook Lane, Cherry Hill, NJ 08003-4099.
NDA 008834Tronothane HCl (pramoxine hydrochloride (HCl))Abbott Laboratories, Dept. PA76/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 009182Gantrisin (sulfisoxazole acetyl)Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199.
NDA 011835Hydrodiuril (hydrochlorothiazide (HCTZ)) TabletsMerck & Co., Inc., P.O. Box 1000, UG2C-50, North Wales, PA 19454.
NDA 011971Oretic (HCTZ) Tablets, 25 milligrams (mg) and 50 mgAbbott Laboratories.
NDA 012302Choloxin (dextrothyroxine sodium) Tablets, 1 mg, 2 mg, 4 mg, and 6 mgDo.
NDA 013402Aldoril (methyldopa/HCTZ) TabletsMerck & Co., Inc.
NDA 015539Serax (oxazepam) Capsules and TabletsAlpharma U.S. Pharmaceuticals Division, c/o King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
NDA 016118Teslac (testolactone) TabletsBristol-Myers Squibb Co.
NDA 016402Alupent (metaproterenol sulfate) Inhalation Aerosol 1Boehringer Ingelheim, 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368.
NDA 016666Hippuran (hippuran I-131) InjectionMallinckrodt Medical Inc., c/o Covidien, 675 McDonnell Blvd., Hazelwood, MO 63042.
NDA 016979Megace (megestrol acetate) Tablets, 20 mg and 40 mgBristol-Myers Squibb Co.
NDA 017015Pavulon (pancuronium bromide) InjectionOrganon USA Inc., c/o Schering-Plough Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033-0530.
NDA 017352Fastin (phentermine HCl) CapsulesGlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398.
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NDA 017628Tolectin (tolmetin sodium) Tablets, 200 mg and 600 mgOrtho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560-0200.
NDA 017920Tagamet (cimetidine) Tablets, 100 mg, 200 mg, 300 mg, 400 mg, and 800 mgGlaxoSmithKline.
NDA 017924Tagamet (cimetidine) Oral Solution, 300 mg/5 milliliters (mL)Do.
NDA 017933Lente Iletin (insulin zinc suspension purified beef-pork)Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
NDA 017934Similente Iletin (insulin zinc suspension purified beef-pork)Do.
NDA 017939Tagamet (cimetidine) Injection, 150 mg/mLGlaxoSmithKline.
NDA 018084Tolectin DS (tolmetin sodium) CapsulesOrtho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC.
NDA 018096Dextrose and Sodium Chloride Injection USPHospira, Inc.
NDA 018118Lanoxicaps (digoxin) CapsulesGlaxoSmithKline.
NDA 018201Moduretic (amiloride HCl/HCTZ) TabletsMerck & Co., Inc.
NDA 018380Sodium Chloride Irrigation USPDo.
NDA 018590Aminocaproic Acid Injection USP, 250 mg/mLBaxter Healthcare Corp.
NDA 018776Norcuron (vecuronium bromide) InjectionOrganon USA Inc., c/o Schering-Plough Corp.
NDA 018869Nimotop (nimodipine) CapsulesBayer Healthcare Pharmaceuticals, Inc., P.O. Box 1000, Montville, NJ 07045.
NDA 019008Bretylium Tosylate in Dextrose Injection USPHospira, Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045-5046.
NDA 019030Bretylium Tosylate Injection USP, 50 mg/mLHospira, Inc.
NDA 019058Tenormin (atenolol) Injection, 5 mg/10 mLAstraZeneca Pharmaceuticals LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-89355.
NDA 019091Ismo (isosorbide mononitrate) Tablets, 20 mgPromius Pharma, LLC, 200 Somerset Corporate Blvd., 7th Floor, Bridgewater, NJ 08807.
NDA 019165Protamine Zinc (insulin zinc suspension beef)Eli Lilly and Co.
NDA 019168Lente Insulin (insulin zinc suspension beef)Do.
NDA 019204Cartrol (carteolol HCl) TabletsAbbot Laboratories.
NDA 019377Humulin L (insulin zinc suspension recombinant human) InjectionDo.
NDA 019434Tagamet (cimetidine HCl) in Sodium Chloride Injection, Equivalent to (EQ) 6 mg Base/mLGlaxoSmithKline.
NDA 019546Dynacirc (isradipine) CapsulesSmithKline Beecham Corp., d/b/a GlaxoSmithKline, One Franklin Plaza, 200 North 16th St., Philadelphia, PA 19102.
NDA 019561Micro-K LS (potassium chloride)KV Pharmaceutical Co., One Corporate Woods Dr., Bridgeton, MO 63044.
NDA 019571Humulin U (insulin zinc suspension extended recombinant human) InjectionEli Lilly and Co.
NDA 019583Relafen (nabumetone) TabletsSmithKline Beecham Corp., c/o GlaxoSmithKline, 2301 Renaissance Blvd., RN210, P.O. Box 61540, King of Prussia, PA 19406.
NDA 019591Lariam (mefloquine HCl) Tablets, 250 mgHoffmann-La Roche Inc.
NDA 019638Arduan (pipecuronium bromide) InjectionOrganon USA Inc., c/o Schering-Plough Corp.
NDA 019735Floxin (ofloxacin) TabletsOrtho-McNeil-Janssen Pharmaceuticals, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, P.O. Box 300, 920 Route 202 South, Raritan, NJ 08869-0602.
NDA 019979Ticlid (ticlopidine HCl) TabletsRoche Palo Alto LLC, c/o Hoffmann-La Roche Inc., 340 Kingsland St., Nutley, NJ 07110-1199.
NDA 020027Cardizen (diltiazem HCl) InjectionBiovail Technologies Ltd., On Behalf of Biovail Laboratories International SRL, 700 Route 202/206 North, Bridgewater, NJ 08807.
NDA 020100Humulin 50/50 (insulin recombinant human and insulin suspension isophane recombinant human)Eli Lilly and Co.
NDA 020269Dobutamine HCl in 5% Dextrose InjectionHospira, Inc.
NDA 020507Teczem (enalapril maleate/diltiazem maleate) Extended-Release TabletsBiovail Technologies, Ltd.
NDA 020548Flovent (fluticasone propionate) Inhalation Aerosol 1GlaxoSmithKline.
NDA 020549Flovent (fluticasone propionate) Inhalation PowderDo.
NDA 020668Lexxel (enalapril maleate and felodipine) Extended-Release TabletsAstraZeneca Pharmaceuticals LP.
NDA 020792Cardizem (diltiazem HCl) InjectionBiovail Technologies, Ltd.
NDA 020906Etopophos (estoposide phosphate) InjectionBristol-Myers Squibb Co.
NDA 020939Diltiazem HCl Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, and 420 mgBiovail Technologies, Ltd.
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NDA 020961Vitravene (fomivirsen sodium) InjectionNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080.
NDA 020966Sporanox (itraconazole) InjectionOrtho-McNeil-Janssen Pharmaceuticals, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC.
NDA 021084Skin Exposure Reduction Paste Against Chemical Warfare Agent (SERPACWA) (polyetrafluoroethylene and perfluoropolymethylisopropyl ether)U.S. Army Medical Material Development Activity, c/o Office of Surgeon General, 1430 Veterans Dr., Fort Detrick, MD 21702-9234.
NDA 021088Viadur (leuprolide acetate) ImplantOrtho-McNeil-Janssen Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC.
NDA 021281Prevacid (lansoprazole)Takeda Global Research and Development Center, Inc., One Takeda Parkway, Deerfield, IL 60015.
NDA 021435Amvaz (amlodipine maleate) Tablets, 2.5 mg, 5 mg, and 10 mgDr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd., Bldg. II, 7th Floor, Bridgewater, NJ 08807-2862.
NDA 021486Lidopel (lidocaine HCl and epinephrine) SolutionEmpi, Inc., P.O. Box 709, Highway 22 East, Clear Lake, SD 57226.
NDA 021507Prevacid NapraPac 250, Prevacid NapraPac 375, and Prevacid NapraPac 500 (lansoprazole and naproxen) TabletsTakeda Global Research and Development Center, Inc.
NDA 021566Prevacid I.V. (lansoprazole) InjectionDo.
NDA 021592Foradil Certihaler (formoterol fumarate) Inhalation PowderNovartis Pharmaceuticals Corp.
NDA 021850Zegerid (omeprazole/sodium bicarbonate/magnesium hydroxide)Santarus, Inc., 3721 Valley Center Dr., suite 400, San Diego, CA 92130.
ANDA 040013Lidocaine HCl Injection USP, 1%Hospira, Inc.
ANDA 040073Naphazoline HCl Ophthalmic Solution USP, 0.1%Bausch & Lomb, Inc., 7 Giralda Farms, suite 1001, Madison, NJ 07940.
ANDA 040095Heparin Sodium Injection USP, 10,000 Units/mLHospira, Inc.
ANDA 040224Chlorpromazine HCl Oral Concentrate USP, 100 mg/mLPharmaceutical Associates, Inc., 201 Delaware St., Greenville, SC 29605.
ANDA 040360Perphenazine Oral Solution USP, 16 mg/5 mLDo.
ANDA 040522Norepinephrine Bitartrate Injection USP, EQ 1 mg (base)/1 mLMetrics Pharmaceuticals Ventures, LLC, c/o Pharmaforce Inc., 960 Crupper Ave., Columbus, OH 43229.
NDA 050521Ceclor (cefaclor) Capsules, 250 mg and 500 mgEli Lilly and Co.
NDA 050522Ceclor (cefaclor) SuspensionDo.
NDA 050560Cefizox (ceftizoxime sodium) Powder for InjectionAstellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015.
ANDA 061394Principen (ampicillin for oral suspension USP)Apothecon, Inc., c/o Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
ANDA 061886Trimox (amoxicillin for oral suspension USP), 50 mg/mL, 125 mg/5 mL, and 250 mg/5 mLDo.
ANDA 062336Mutamycin (mitomycin for injection USP) 5 mg, 20 mg, and 40 mg VialsBristol-Myers Squibb Co.
ANDA 062557Kefzol (cefazolin sodium for injection USP)Eli Lilly and Co.
ANDA 062563Erythromycin Lactobionate for Injection USPElkins-Sinn, Inc., c/o Baxter Healthcare Corp., 2 Esterbrook Lane, Cherry Hill, NJ 08003-4002.
ANDA 062885Trimox (amoxicillin for oral suspension USP), 125 mg/5 mL and 250 mg/5 mLApothecon, Inc., c/o Bristol-Myers Squibb Co.
ANDA 062993Erythromycin Lactobionate for Injection USP, EQ 500 mg (base) and 1 gram (g) (base) VialsBaxter Healthcare Corp.
ANDA 063294Cefizox (ceftizoxime for injection USP), EQ 1 g (base) and 2 g (base) VialsAstellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2548.
ANDA 070225Verapamil HCl Injection USP, 2.5 mg/mLLuitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O. Box 9001, Shirley, NY 11967.
ANDA 070231Carbamazepine Tablets USP, 200 mgInwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311.
ANDA 070291Methyldopate HCl Injection USP, 50 mg/mLBaxter Healthcare Corp.
ANDA 070617Verapamil HCl Injection USP, 2.5 mg/mLLuitpold Pharmaceuticals, Inc.
ANDA 070891Bretylium Tosylate Injection USP, 50 mg/mLDo.
ANDA 072058Pancuronium Bromide Injection, 1 mg/mLElkins-Sinn, Inc., c/o Baxter Healthcare Corp.
ANDA 072059Pancuronium Bromide Injection, 2 mg/mLDo.
ANDA 072060Pancuronium Bromide Injection, 2 mg/mLDo.
ANDA 072272Droperidol Injection USP, 2.5 mg/mLHospira, Inc.
ANDA 072335Droperidol Injection USP, 2.5 mg/mLLuitpold Pharmaceuticals, Inc.
ANDA 074188Dipivefrin HCl Ophthalmic Solution USP, 0.1%Bausch & Lomb, Inc.
ANDA 074320Etoposide Injection, 20 mg/mLHospira, Inc.
ANDA 074351Etoposide Injection, 20 mg/mLDo.
ANDA 074353Cimetidine HCl Injection USPLuitpold Pharmaceuticals, Inc.
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ANDA 074381Dobutamine Injection USP, 12.5 mg (base)/mLBaxter Healthcare Corp.
ANDA 074545Dobutamine Injection USP, 12.5 mg/mLLuitpold Pharmaceuticals, Inc.
ANDA 074634Dobutamine Injection USP, 12.5 mg/mLHospira, Inc.
ANDA 074643Minoxidil Topical Solution, 2%Bausch & Lomb, Inc.
ANDA 074743Minoxidil Topical Solution, 2%Sight Pharmaceuticals, Inc., 7 Giralda Farms, suite 1001, Madison, NJ 07940.
ANDA 074824Atracurium Besylate Injection USP, 10 mg/mLBaxter Healthcare Corp.
ANDA 074825Atracurium Besylate Injection USP, 10 mg/mLDo.
ANDA 075341Ketoconazole Tablets USP, 200 mgAAIPharma Service Corp., 2320 Scientific Park Dr., Wilmington, NC 28405.
ANDA 075456Enalaprilat Injection, 1.25 mg/mLHospira, Inc.
ANDA 075542Amrinone (inamrinone injection USP) EQ 5 mg/mLBaxter Healthcare Corp.
ANDA 076617Fluconazole in Sodium Chloride 0.9% InjectionHospira, Inc.
ANDA 076656Fenoldopam Mesylate Injection USP, EQ 10 mg (base)/mLLuitpold Pharmaceuticals, Inc.
ANDA 076695Ondansetron Injection USP, EQ 2 mg (base)/mLHospira, Inc.
ANDA 076696Ondansetron Injection USP, EQ 2 mg (base)/mLDo.
ANDA 077065Terbinafine HCl Tablets, EQ 250 mg (base)Gedeon Richter PLC, c/o Gedeon Richter USA, Inc., 1200 East Ridgewood Ave., Ridgewood, NJ 07450.
ANDA 077333Amlodipine Besylate Tablets, EQ 2.5 mg (base), 5 mg (base), and 10 mg (base)Do.
ANDA 077389Carboplatin InjectionTeva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 077392Lamotrigine Tablets, 25 mg, 100 mg, 150, mg, and 200 mgRoxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228.
ANDA 077994Ironotecan HCl InjectionSandoz, Inc., 2555 West Midway Blvd., Broomfield, CO 80038-0446.
ANDA 080416Procaine HCl Injection USP, 1% and 2%Hospira, Inc.
ANDA 083346Isoproterenol HCl Injection USP, 0.2 mg/mLDo.
ANDA 084178Methyltestosterone Tablets, 5 mgKV Pharmaceutical Co., One Corporate Woods Dr., Bridgeton, MO 63044.
ANDA 084179Methyltestosterone Tablets, 25 mgDo.
ANDA 084312Methyltestosterone Tablets, 10 mgDo.
ANDA 084767Dimenhydrinate Injection USPBaxter Healthcare Corp.
ANDA 085284Aminophylline Tablets, 100 mgKV Pharmaceutical Co.
ANDA 085285Secobarbital Sodium Capsules, 100 mgDo.
ANDA 085289Aminophylline Tablets, 200 mgDo.
ANDA 085363Acetaminophen and Codeine Phosphate Tablets, 325 mg/45 mgDo.
ANDA 085384Triprolidine HCl Syrup, 1.25mg/5 mLDo.
ANDA 085385Promethazine HCl Syrup, 25 mg/5 mLDo.
ANDA 085388Promethazine HCl Syrup, 6.25 mg/5 mLDo.
ANDA 085466Brompheniramine Maleate Elixir, 2 mg/5 mLDo.
ANDA 085492Acetic Acid with Hydrocortisone Otic Solution, 2%/1%Do.
ANDA 085493Acetic Acid Otic Solution, 2%Do.
ANDA 085551Hydroxyzine HCl Injection USP, 25 mg/mL and 50 mg/mLBaxter Healthcare Corp.
ANDA 085621Diphenhydramine HCl Elixir, 12.5 mg/5 mLKV Pharmaceutical Co.
ANDA 085810Prednisone Tablets, 5 mgDo.
ANDA 086619Hydrocortisone Sodium Succinate for Injection USP, EQ 100 mg (base)/VialBaxter Healthcare Corp.
ANDA 086661Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) ElixirA.H. Robins Co., c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299.
ANDA 086676Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) TabletsDo.
ANDA 086677Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr)) CapsulesDo.
ANDA 086797Novocain (procaine HCl injection USP) 10%Hospira, Inc.
ANDA 086906Methylprednisolone Sodium Succinate for Injection USP, EQ 40 mg (base), 125 mg (base), 500 mg (base), and 1 g (base) VialsElkins-Sinn, Inc., c/o Baxter Healthcare Corp.
ANDA 087239Aminophylline Injection USP, 25 mg/mLDo.
ANDA 087240Aminophylline Injection USP, 25 mg/mLLuitpold Pharmaceuticals, Inc.
ANDA 087311Chlorthalidone Tablets, 25 mgKV Pharmaceutical Co.
ANDA 087312Chlorthalidone Tablets, 50 mgDo.
ANDA 087506Muro Opcon (naphazoline HCl ophthalmic solution USP, 0.1%)Bausch & Lomb, Inc.
ANDA 087567Hydrocortisone Sodium Succinate for Injection USP, EQ 250 mg (base)/VialBaxter Healthcare Corp.
ANDA 087568Hydrocortisone Sodium Succinate for Injection USP, EQ 500 mg (base)/VialDo.
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ANDA 087569Hydrocortisone Sodium Succinate for Injection USP, EQ 1 g (base)/VialDo.
ANDA 087584Potassium Chloride for Injection Concentrate USPLuitpold Pharmaceuticals, Inc.
ANDA 087601Aminophylline Injection USP, 25 mg/mLHospira, Inc.
ANDA 087956Vitamin K1 (phytonadione injection emulsion USP), 10 mg/mLDo.
ANDA 088279Meperidine HCl Injection USP, 25 mg/mLBaxter Healthcare Corp.
ANDA 088280Meperidine HCl Injection USP, 50 mg/mLDo.
ANDA 088281Meperidine HCl Injection USP, 75 mg/mLDo.
ANDA 088282Meperidine HCl Injection USP, 100 mg/mLDo.
ANDA 088326Lidocaine HCl Injection USP, 1.5%Hospira, Inc.
ANDA 088331Lidocaine HCl Injection USP, 2%Do.
ANDA 088368Lidocaine HCl Injection USP, 20%Do.
ANDA 088371Cyclophosphamide for Injection USP, 100 mg/VialBaxter Healthcare Corp.
ANDA 088372Cyclophosphamide for Injection USP, 200 mg/VialDo.
ANDA 088373Cyclophosphamide for Injection USP, 500 mg/VialDo.
ANDA 088374Cyclophosphamide for Injection USP, 1 g/VialDo.
ANDA 089649Lidocaine HCl and Epinephrine InjectionHospira, Inc.
ANDA 089703Prochlorperazine Edisylate Injection USP, EQ 5 mg (base)/mLDo.
ANDA 089707Perphenazine Tablets USP, 2 mgIvax Pharmaceuticals Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 090954Cromolyn Sodium Oral Solution Concentrate, 100 mg/5 mLPack Pharmaceuticals, LLC, 1110 West Lake Cook Rd., suite 152, Buffalo Grove, IL 60089.
1 This product was an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any metaproterenol sulfate or fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241, April 14, 2010; 71 FR 70870-70873, December 7, 2006).

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 of Food and Drugs, approval of the applications listed in table 1 of this document, and all amendments and supplements thereto, is hereby withdrawn, effective July 8, 2011. 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 of this document 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.

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Dated: May 31, 2011.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 2011-14164 Filed 6-7-11; 8:45 am]