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Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.

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The Food and Drug Administration (FDA) is withdrawing approval of 76 new drug applications (NDAs) and 60 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


April 4, 2005.

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Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing.

Application No.DrugApplicant
NDA 6-095Tubocurarine Chloride InjectionHospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, IL 60045-5046
NDA 6-412Decapryn (doxylamine succinate) Tablets and SyrupAventis Pharmaceuticals, Inc., 200 Crossing Blvd., Bridgewater, NJ 08807-0890
NDA 6-460Protamine Sulfate Injection USPEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 8-032Telepaque (iopanoic acid) TabletsAmersham Health, 101 Carnegie Center, Princeton, NJ 08540
NDA 10-288Betadine (10% povidone iodine) Solution and Isodine (10% povidone iodine) SolutionThe Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431
NDA 11-097Dimetane (brompheniramine maleate) ElixirWyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940
NDA 11-270Furoxone (furazolidone) TabletsShire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850
NDA 11-323Furoxone (furazolidone) Oral SuspensionDo.
NDA 11-325Vesprin (triflupromazine hydrochloride (HCl)) Injection, 10 milligrams (mg)/milliliter (mL) and 20 mg/mLApothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500
NDA 11-367Enzactin (triacetin) SprayWyeth Consumer Healthcare
NDA 12-265Naqua (trichlormethiazide) Tablets and Naquival (trichlormethiazide and reserpine) TabletsSchering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 12-320Rauzide (rauwolfia serpentine with bendroflumethiazide) Tablets and Rautrax-N TabletsApothecon, c/o Bristol-Myers Squibb Co.
NDA 12-728Ortho-Novum 1/50-21 (norethindrone and mestranol) TabletsOrtho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C., 920 Route 202 South, Box 300, Raritan, NJ 08869-0602
NDA 16-993Adsorbotear Ophthalmic SolutionAlcon Laboratories, Inc., 6201 South Freeway, Fort Worth, TX 76134
NDA 17-471Sodium Pertechnetate Tc-99m (technetium Tc-99m sodium pertechnetate) SolutionAmersham Health
NDA 17-488Modicon 21 (norethindrone and ethinyl estradiol) TabletsOrtho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C.
NDA 17-489Ortho-Novum 1/35-21 (norethindrone and ethinyl estradiol) Tablets and Neocon Tablets (norethindrone and ethinyl estradiol)Do.
NDA 17-561Celstone (betamethasone sodium phosphate USP) InjectionSchering Corp.
NDA 17-601Optimine (azatadine maleate USP) TabletsDo.
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NDA 17-603Novafed ER (pseudoephedrine HCl) Tablets, 120 mgAventis Pharmaceuticals, Inc.
NDA 17-657Cephulac (lactulose fumarate) SyrupDo.
NDA 17-661Tavist (clemastine fumarate) Tablets and Tavist-1 (clemastine fumarate) TabletsNovartis Consumer Health, Inc., 200 Kimball Dr., Parsippany, NJ 07054-0622
NDA 17-687Xenon Xe-133 GasAmersham Health
NDA 17-700Gallium Citrate Ga-67 InjectionDo.
NDA 17-773Technetium Tc-99m MAA KitAmersham Health
NDA 17-884Chronulac (lactulose) SyrupAventis Pharmaceuticals, Inc.
NDA 18-030Dextrose and Sodium Chloride (NaCl) Injection USPB. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623-9791
NDA 18-062Proventil (albuterol sulfate) SyrupSchering Corp.
NDA 18-229Dextrose and NaCl Injection USPB. Braun Medical, Inc.
NDA 18-269Isolyte E (multi-electrolyte injection) with 5% DextroseDo.
NDA 18-270Isolyte M (multi-electrolyte injection) with 5% DextroseDo.
NDA 18-271Isolyte R (multi-electrolyte injection) with 5% DextroseDo.
NDA 18-273Isolyte H (multi-electrolyte injection) with 5% DextroseDo.
NDA 18-335Amerscan (technetium Tc-99m medronate) MDP KitAmersham Health
NDA 18-358Dextrose Injection USP, 2.5%B. Braun Medical, Inc.
NDA 18-386Dextrose and NaCl Injection USPDo.
NDA 18-506Trinalin Repetabs (azatadine maleate and pseudoephedrine sulfate tablets)Schering Corp.
ANDA 18-621Nitro-Bid IV (nitroglycerin) Injection, 5 mg/mLAventis Pharmaceuticals, Inc.
NDA 18-654Versed (midazolam HCl) InjectionHoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199
NDA 18-675Tavist (clemastine fumarate) SyrupNovartis Consumer Health, Inc.
ANDA 18-889Metronizadole in NaCl InjectionAbbott Laboratories, 200 Abbott Park Rd., D-389 J45-2, Abbott Park, IL 60064-6133
NDA 18-899Isolyte E (multi-electrolyte injection)B. Braun Medical, Inc.
NDA 18-924Aminophylline in 0.45% NaCl InjectionHospira, Inc.
NDA 18-967Lidocaine HCl and 5% Dextrose InjectionB. Braun Medical, Inc.
NDA 19-004Ortho-Novum (nonrethindrone and ethinyl estradiol) 7/14-21 and -28 TabletsOrtho-McNeil Pharmaceuticals, Inc., c/o Johnson & Johnson Research and Development, L.L.C.
NDA 19-006Isolyte S, pH 7.4 (multi-electrolyte injection)B. Braun Medical, Inc.
NDA 19-025Isolyte P (multi-electrolyte injection) with 5% Dextrose Do.
NDA 19-033Bretylium Tosylate InjectionHospira, Inc.
NDA 19-042Heparin Sodium in NaCl InjectionB. Braun Medical, Inc.
NDA 19-077Sterile Water for Injection USPDo.
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NDA 19-134Heparin Sodium in 5% Dextrose InjectionDo.
NDA 19-135Heparin Sodium in 0.9% NaCl InjectionDo.
NDA 19-243Proventil (albuterol sulfate) Inhalation SolutionSchering Corp.
NDA 19-471Cardizem SR Capsules (diltiazem HCl), 60 mg, 90 mg, 120 mg, and 180 mgBiovail Laboratories, Inc., c/o Biovail Technologies Ltd., 700 Route 202/206 North, Bridgewater, NJ 08807-0980
NDA 19-478Adalat (nifedipine) CapsulesBayer Pharmaceuticals Corp., 400 Morgan Lane, West Haven, CT 06516-4175
NDA 19-604Volmax (albuterol sulfate) Extended- Release TabletsMuro Pharmaceuticals, Inc., 890 East St., Tewksbury, MA 01876-1496
NDA 19-616Penetrex (enoxacin) TabletsAventis Pharmaceuticals, Inc.
NDA 19-698Toradol (ketorolac tromethamine) InjectionRoche Palo Alto, LLC, c/o Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110
NDA 19-817Persantine (dipyridamole) InjectionBoehringer Ingleheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
NDA 19-978Bupivacaine HCl Injection USPHospira, Inc.
NDA 20-542Dopamine HCl in 5% Dextrose InjectionDo.
NDA 20-677Zagam (sparfloxacin) Tablets, 200 mgMylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310
NDA 20-755Caverject (alprostadil) InjectionPfizer, Inc., 7000 Portage Rd., Kalamazoo, MI 49001
NDA 20-942Versed (midazolam HCl) Syrup, 2 mg/mLHoffman-La Roche, Inc.
NDA 20-997Chirocaine (levobupivacaine HCl) InjectionPurdue Pharma L.P., One Stamford Forum, Stamford, CT 06901-3431
NDA 50-010Ilosone (erythromycin estolate oral suspension) LiquidEli Lilly & Co.
NDA 50-011Pathocil (dicloxacillin sodium) CapsulesWyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 50-199Unipen (nafcillin sodium) Powder for Oral SolutionDo.
NDA 50-271Achromycin (tetracycline HCl) Powder for ReconstitutionLederle, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 50-320Unipen (nafcillin sodium) InjectionWyeth Pharmaceuticals
NDA 50-365Ilosone (erythromycin estolate USP) PulvulesEli Lilly & Co.
NDA 50-369Ilotycin (erythromycin) TabletsDo.
NDA 50-426Ilosone (erythromycin estolate USP) TabletsDo.
NDA 50-427Minocin (minocycline HCl) Diagnostic Susceptibility PowderLederle, c/o Wyeth Pharmaceuticals
NDA 50-437Garamycin (gentamicin sulfate) Injection, 10 mg/mLSchering Corp.
NDA 50-462Unipen (nafcillin sodium) TabletsWyeth Pharmaceuticals
NDA 50-505Garamycin (gentamicin sulfate) Injection, 2 mg/mLSchering Corp.
NDA 50-549Mezlin (mezlocillin sodium monohydrate) Sterile Powder for InjectionBayer Pharmaceuticals Corp.
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ANDA 60-134Ledercillin VK (penicillin V potassium) Tablets, 250 mg and 500 mgLederle Laboratories, Pearl River, NY 10965
ANDA 60-136Ledercillin VK (penicillin V potassium) for Oral Suspension, 125 mg/5 mL and 250 mg/5 mLDo.
ANDA 60-413Penicillin G Potassium TabletsWyeth Laboratories
ANDA 60-431Ilosone (erythromycin estolate USP) Chewable TabletsLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
ANDA 60-559Ilosone (erythromycin estolate) Oral Suspension LiquidDo.
ANDA 60-625Omnipen (ampicillin for oral suspension USP) for Oral SuspensionWyeth Laboratories
ANDA 60-626Omnipen-N (ampicillin sodium) Injection, 125 mg, 250 mg, 500 mg, 1 gram (g), and 2 g/vialDo.
ANDA 61-655Kantrex (kanamycin sulfate) InjectionApothecon, c/o Bristol-Myers Squibb Co.
ANDA 61-675Wyamycin S (erythromycin stearate tablets USP), 250 mg and 500 mgWyeth Laboratories
ANDA 61-685Tetracycline HCl Capsules USP, 250 mg and 500 mgDo.
ANDA 61-769Cephapirin for Injection USPApothecon, c/o Bristol-Myers Squibb Co.
ANDA 61-893Ilosone (erythromycin estolate USP) for Oral SuspensionDista, c/o Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
ANDA 61-894Ilosone (erythromycin estolate) Oral SuspensionDo.
ANDA 61-895Ilosone (erythromycin estolate USP) Chewable TabletsDo.
ANDA 61-896Ilosone (erythromycin estolate USP) TabletsDo.
ANDA 61-897Ilosone (erythromycin estolate USP) PulvulesDo.
ANDA 61-910Ilotycin (erythromycin) Enteric Coated TabletsDo.
ANDA 62-123Wyamycin E (erythromycin ethylsuccinate) Oral Suspension, 200 mg/5 mL and 400 mg/5 mLWyeth Laboratories
ANDA 62-131Wymox (amoxicillin) for Oral SuspensionDo.
ANDA 62-501Gentacidin Ophthalmic Ointment (gentamicin sulfate ophthalmic ointment USP) 0.3%Novartis Ophthalmics, Inc., 11695 John Creek Pkwy., Duluth, GA 30097-1523
ANDA 62-544Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic SuspensionNovartis Pharmaceuticals Corp., One Health Plaza, Building 105 Eisenhower, East Hanover, NJ 07936
ANDA 62-566Dexacidin (neomycin sulfate, polymyxin B sulfate, and dexamethasone) Ophthalmic OintmentNovartis Ophthalmics, Inc.
ANDA 62-717Unipen (nafcillin sodium) Injection, 500-mg, 1-g, and 2-g vialsWyeth Laboratories
ANDA 62-718Omnipen-N (ampicillin sodium) Injection, 125-mg, 250-mg, 500-mg, 1-g, and 2-g vialsDo.
ANDA 62-726Kenamycin Sulfate Capsules USP, 500 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 62-986Cephalexin For Oral Suspension USP, 125 mg/5 mLDo.
ANDA 63-107Emgel (erythromycin) Topical Gel, 2%GlalxoSmithKline Consumer Healthcare, L.P., 1500 Littleton Rd., Parsippany, NJ 07054-3884
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ANDA 71-159Nitro-Bid (nitroglycerin) Injection, 10 mg/mLAventis Pharmaceuticals, Inc.
ANDA 74-194Loperamide HCl Tablets, 2 mgL. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010
ANDA 74-539Tamoxifen Citrate Tablets USP, 10 mgPharmachemie B.V., c/o Teva Pharmaceuticals, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454-1090
ANDA 75-114Acyclovir Injection, 50 mg/mLAbbott Laboratories
ANDA 75-583Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mgApothecon Inc., c/o Bristol-Myers Squibb Co.
ANDA 75-729Famotidine Injection, 0.4 mg/mLAbbott Laboratories
ANDA 76-214Sotalol HCl Tablets, 80 mg, 120 mg, and 160 mgTorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069
ANDA 83-823Nicolar (niacin) Tablets, 500 mgAventis Pharmaceuticals, Inc.
ANDA 83-892Selenium Sulfide Lotion USPAllergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623
ANDA 84-476Domeboro (acetic acid, glacial and aluminum acetate) Solution Bayer Pharmaceuticals Corp.
ANDA 85-113Chlordiazepoxide HCl Capsules USP, 10 mgImpax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544
ANDA 85-187Slo-Phyllin (theophylline) Syrup, 80 mg/15 mLAventis Pharmaceuticals, Inc.
ANDA 85-202Slo-Phyllin (theophylline) Tablets, 100 mgDo.
ANDA 85-204Slo-Phyllin (theophylline) Tablets, 200 mgDo.
ANDA 86-126Nitrong SR (nitroglycerin) Tablets, 6.5 mgDo.
ANDA 86-137Nitrong (nitroglycerin) Ointment, 2%Do.
ANDA 86-138Nitrong (nitroglycerin) Tablets, 2.6 mgDo.
ANDA 86-681Acetaminophen and Codeine Phospate Tablets USP, 300 mg/30 mgPurepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207
ANDA 87-715Nitrong SR (nitroglycerin) Tablets, 9 mgDo.
ANDA 87-892Slo-Bid (theophylline) Capsules, 100 mgAventis Pharmaceuticals, Inc.
ANDA 87-893Slo-Bid (theophylline) Capsules, 200 mgDo.
ANDA 87-894Slo-Bid (theophylline) Capsules, 300 mgDo.
ANDA 88-082Hydrocortisone USP, Micronized Powder (Nonsterile)Paddock Laboratories, Inc., 3940 Quebec Ave. South, Minneapolis, MN 55427
ANDA 88-269Slo-Bid (theophylline) Capsules, 50 mgAventis Pharmaceuticals, Inc.
ANDA 88-782NTS 5 (nitroglycerin) Transdermal SystemsHercon Laboratories Corp., 101 Sinking Springs Lake, P.O. Box 467, Emigsville, PA 17318
ANDA 88-783NTS 15 (nitroglycerin) Transdermal SystemsDo.
ANDA 88-791Vasocidin (sulfacetamide sodium and prednisolone acetate) Ophthalmic OintmentNovartis Ophthalmics, Inc.
ANDA 89-047Sulf-15 (sulfacetamide sodium ophthalmic solution USP), 15%Do.
ANDA 89-516NTS 10 (nitroglycerin) Transdermal SystemsHercon Laboratories Corp.
ANDA 89-539Slo-Bid (theophylline) Capsules, 75 mgAventis Pharmaceuticals, Inc.
ANDA 89-540Slo-Bid (theophylline) Capsules, 125 mgDo.
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Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic 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 the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective April 4, 2005.

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Dated: January 31, 2005.

Steven Galson,

Acting Director, Center for Drug Evaluation and Research.

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[FR Doc. 05-4158 Filed 3-3-05; 8:45 am]