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Schering Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 92 new drug applications (NDAs) and 49 abbreviated new drug applications (ANDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


June 4, 2004

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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.

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Application No.DrugApplicant
NDA 5-292Estinyl (ethinyl estradiol) TabletsSchering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 5-795Furacin (nitrofurazone)Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850
NDA 6-110Dienestrol (dienestrol) CreamOrtho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Research & Development, L.L.C., 920 Highway 202, P.O. Box 300, Raritan, NJ 08869#ndash;0602
NDA 6-800Paradione (paramethadione)Abbott Laboratories, D-491/AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157
NDA 7-110Cortone Acetate (cortisone acetate injectable suspension USP) Injectable SuspensionMerck & Co., Inc., Sumneytown Pike, BLA-20, P.O. Box 4, West Point, PA 19486
NDA 7-707Phenurone (phenacemide) TabletsAbbott Laboratories
NDA 7-750Cortone Acetate (cortisone acetate tablet USP) TabletsMerck & Co., Inc.
NDA 8-328SpectrocinBristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000
NDA 8-604Phenergan VC Syrup (promethazine hydrochloride (HCl) and phenylephrine HCl) and Phenergan Expectorant (promethazine HCl, ipecac, and potassium guaiacolsulfonate)Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 8-857Phenergan Injection (promethazine HCl)Do.
NDA 9-298Amm-I-Dent (sodium lauroyl sarcosinate/urea/ammonium phosphate) Toothpaste and Tooth PowderBlock Drug Co., Inc., 257 Cornelison Ave., Jersey City, NJ 07302
NDA 10-039Avlosulfon (dapsone) TabletsWyeth Pharmaceuticals
NDA 10-727Peri-Colace Capsules (30 milligrams (mg) casanthranol/100 mg docusate sodium) and Syrup (30 mg casanthranol/60 mg docusate sodium per 15 milliliters (mL))Shire Pharmaceutical Development, Inc.
NDA 10-775Trilafon (perphenazine) TabletsSchering Corp.
NDA 10-858Enzactin (triacetin) CreamWyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940-0871
NDA 10-971PMB (conjugated estrogens USP with meprobamate) TabletsWyeth Pharmaceuticals
NDA 11-140Enzactin (triacetin) PowderWyeth Consumer Healthcare
NDA 11-460Lanesta (chlorindanol) Vaginal GelSanofi-Synphelabo, Inc., 90 Park Ave., New York, NY 10016
NDA 11-860Humorsol (demecarium bromide) Ophthalmic SolutionMerck & Co., Inc.
NDA 11-977Decadron Ophthalmic Ointment (dexamethasone sodium phosphate ophthalmic ointment)Do.
NDA 12-052Hydrocortone (hydrocortisone sodium phosphate injection USP) Injection, 50 mg/mLDo.
NDA 12-071Decadron (dexamethasone sodium phosphate injection USP) Injection, 4 mg/mL and 24 mg/mLDo.
NDA 12-095Orinase (sterile tolbutamide sodium) Diagnostic Sterile Powder for InjectionPharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199
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NDA 12-283Hygroton (chlorthalidone) Tablets, 25 mg, 50 mg, and 100 mgAventis Pharmaceuticals, Inc., Mail Stop BX2 - 209G, 200 Crossing Blvd., Bridgewater, NJ 08807-0890
NDA 12-359Salutensin and Salutensin-DEMI (hydroflumethiazide and reserpine) TabletsShire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850
NDA 12-376Decadron (dexamethasone) Elixir, 0.5 mg/5 mLMerck & Co. Inc.
NDA 12-594Metahydrin (trichlormethiazide) Tablets, 2 mg and 4 mgAventis Pharmaceuticals, Inc.
NDA 12-657Celestone (betamethasone tablets USP) TabletsSchering Corp.
NDA 12-972Metatensin (trichlormethiazide and reserpine) Tablets, 2 mg/0.1 mg and 4 mg/0.1 mgAventis Pharmaceuticals, Inc.
NDA 14-116Johnson #Johnson First Aid Spray (dequainium acetate and cetylpyridinium chloride)Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Sillman, NJ 08558
NDA 14-122Protopam (pralidoxime chloride) TabletsWyeth Pharmaceuticals
NDA 14-127Xylocaine (lidocaine) 5% SolutionAstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355
NDA 14-713Etrafon (perphenazine and amitriptyline HCl) and Etrafon Forte TabletsSchering Corp.
NDA 15-103Regroton (chlorthalidone, 50 mg and reserpine, 0.25 mg) and Demi-Regroton (chlorthalidone, 25 mg and reserpine, 0.125 mg) TabletsAventis Pharmaceuticals, Inc.
NDA 16-034Vontrol (diphenidol HCl) InjectionGlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929
NDA 16-035Vontrol (diphenidol pamoate) SuspensionDo.
NDA 16-036Vontrol (diphenidol) SuppositoriesDo.
NDA 16-087Valium (diazepam) InjectionRoche Laboratories, Inc., 340 Kingsland St., Nutley, NJ 07110-1199
NDA 16-110Prolixin (fluphenazine enanthate) Injection, 25 mg/mLApothecon, c/o Bristol-Myers Co., P.O. Box 4500, Princeton, NJ 08543-4500
NDA 16-618Pondimin (fenfluramine HCl) Tablets and Ponderex (fenfluramine HCl) CapsulesA.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 16-647Quinaglute (quinidine gluconate) Dura-TabsBerlex Laboratories, Inc., 340 Changebridge Rd., P.O. Box 1000, Montville, NJ 07045-1000
NDA 16-786Ovral 28 (norgestrel/ethinyl estradiol) and Ferrous Fumarate TabletsWyeth Pharmaceuticals
NDA 16-803Bronkaid (epinephrine inhalation aerosol) MistBayer Consumer Care Division, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910
NDA 16-849Selsun Blue ShampooRoss Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1754
NDA 16-883Antiminth (pyrantel pamoate) Oral SuspensionPfizer Consumer Healthcare, 201 Tabor Rd., Morris Plains, NJ 07950
NDA 16-912Larodopa (levadopa) Tablets and CapsulesHoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199
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NDA 16-985Gleem (sodium fluoride) DentrificeProctor & Gamble Pharmaceuticals, Inc., Oral Care Products Division, 8700 Mason-Montgomery Rd., Mason, OH 45040
NDA 17-020Panwarfin (warfarin sodium tablets USP) Tablets, 2 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 25 mgAbbott Laboratories
NDA 17-389Dial 2 (pyrithione zinc) Dandruff ShampooArmour-Dial, Inc., 15101 N. Scottsdale Rd., Scottsdale, AZ 85260
NDA 17-535Lorelco (probucol) TabletsAventis Pharmaceuticals, Inc.
NDA 17-536Diprosone (betamethasone dipropionate) Cream, 0.05%Schering Corp.
NDA 17-684Pyrolite (technetium Tc-99m pyro- and trimeta-phosphates kit)CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730
NDA 17-710Nalfon (fenoprofen calcium) TabletsDista Products Ltd., c/o Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 17-736Paxipam (halazepam) Tablets, 20 mg and 40 mgSchering Corp.
NDA 17-853Proventil (albuterol sulfate) Tablets, 2 mg and 4 mgDo.
NDA 17-895Janimine (imipramine HCl) TabletsAbbott Laboratories
NDA 17-952Trimpex (trimethoprim) TabletsHoffman-La Roche, Inc.
NDA 18-306NasalCrom (cromolyn sodium) Nasal SolutionPharmacia Consumer Healthcare, 100 Route 206 North, Peapack, NJ 07977
NDA 18-521Vancenase (beclomethasone dipropionate) Nasal InhalerSchering Corp.
NDA 18-584Beconase (beclomethasone dipropionate) Inhalation AerosolGlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709
NDA 18-587Wytensin (guanabenz acetate) Tablets, 4 mg, 8 mg, and 16 mgWyeth Pharmaceuticals
NDA 18-592Monistat 5 (miconazole nitrate) Tampons, 100 mgPersonal Products Co., 199 Grandview Rd., Skillman, NJ 08558
NDA 19-059Inderide LA (propranolol HCl and hydrochlorothiazide) Capsules, 80 mg/50 mg, 120 mg/50 mg, and 160 mg/50 mgAyerst Pharmaceuticals, c/o Wyeth Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 19-279Dimetane DX (brompheniramine maleate/ pseudoephedrine HCl/dextromethorphan HBr) Cough SyrupA.H. Robins Co., c/o Wyeth Pharmaceuticals
NDA 19-428Pseudoephedrine HCl and Chlorpheniramine Maleate Extended-Release CapsulesCentral Pharmaceuticals, c/o Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201
NDA 19-757Chibroxin (norfloxacin) Sterile Ophthalmic Solution, 0.3%Merck &Co., Inc.
NDA 19-858Cipro (ciprofloxacin) in Sodium ChlorideBayer Corp.
NDA 20-055Glyburide (micronized) TabletsAventis Pharmaceuticals, Inc.
NDA 20-058Thioplex (thiotepa) For Injection)Immunex Corp., 51 University St., Seattle, WA 98101-2936
NDA 20-135Motrin (ibuprofen) Chewable TabletsMcNeil Consumer & Specialty Pharmaceuticals, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299
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NDA 20-233Rhinocort (budesomide) Nasal InhalerAstraZeneca LP
NDA 20-240Renormax (spirapril HCl) Tablets, 3 mg, 6 mg, 12 mg, and 24 mgSchering Corp.
NDA 20-418Motrin (ibuprofen) CapletsMcNeil Consumer & Specialty Pharmaceuticals
NDA 20-469Vancenase AQ (beclomethasone dipropionate monohydrate) Nasal SpraySchering Corp.
NDA 20-476Motrin (ibuprofen) Oral DropsMcNeil Consumer &Specialty Pharmaceuticals
NDA 20-874Lunelle (estradiol cypionate and medroxyprogesterone acetate) InjectionPharmacia Corp., c/o Pfizer Pharmaceuticals Group, 235 E. 42d St., New York, NY 10017-5755
NDA 20-951Tagamet HB (cimetidine) SuspensionGlaxoSmithKline Consumer Healthcare LP, 1500 Littleton Rd., Parsippany, NJ 07054-3884
NDA 50-012Garamycin (gentamicin sulfate injection USP) InjectableSchering Corp.
NDA 50-051Grisactin (griseofulvin, microcrystalline) CapsulesWyeth Pharmaceuticals
NDA 50-092Pathocil (dicloxacillin sodium) for SuspensionDo.
NDA 50-094Erythrocin (erythromycin) SuppositoriesAbbott Laboratories
NDA 50-111Unipen (nafcillin sodium) CapsulesWyeth Pharmaceuticals
NDA 50-262Declomycin (demeclocycline HCl) CapsulesLederle Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 50-273Achromycin (tetracycline HCl) Intravenous InjectionDo.
NDA 50-276Achromycin (tetracyclilne HCl and procaine HCl) Sterile Intramuscular InjectionDo.
NDA 50-296Erythrocin SuspensionAbbott Laboratories
NDA 50-324Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Ophthalmic OintmentMerck Research Laboratories, Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004
NDA 50-341Fungizone (amphotericin B) Oral SuspensionBristol-Myers Squibb Co.
NDA 50-425Garamycin (gentamicin sulfate) Ophthalmic OintmentSchering Corp.
NDA 50-439Erythrocin (erythromycin stearate)Abbott Laboratories
NDA 50-482Keflin (cephalothin sodium) for InjectionLilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
NDA 50-744Periostat (doxycycline hyclate USP) Capsules, 20 mgCollaGenex Pharmaceuticals, Inc., 301 South State St., Newtown, PA 18940
ANDA 60-006Pen-Vee K (penicillin V potassium) Tablets, 125 mg, 250 mg, and 500 mg (base)Wyeth Pharmaceuticals
ANDA 60-611Neomycin Sulfate and Methylprednisolone Acetate Topical CreamPharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001
ANDA 60-624Omnipen (ampicillin) Capsules, 250 mg and 500 mgWyeth Pharmaceuticals
ANDA 62-178Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 125 mg and 250 mgDo.
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ANDA 62-438Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 165 mg and 330 mgDo.
ANDA 62-549Keflin (cephalothin sodium for injection USP), 1 g and 2 gLilly Research Laboratories
ANDA 62-690Ticar (ticarcillin disodium) Injection, 3 gGlaxoSmithKline
ANDA 62-905Clindamycin Phosphate Injection USP, 150 mg/mLLoch Pharmaceuticals, c/o Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146
ANDA 63-087Lincomycin HCl USPAbbott Laboratories
ANDA 63-321Vancoled (vancomycin HCl for oral solution USP)Lederle Laboratories, c/o Wyeth Pharmaceuticals
ANDA 70-188Naloxone HCl Injection USP, 0.02 mg/mLWyeth Pharmaceuticals
ANDA 70-189Naloxone HCl Injection USP, 0.02 mg/mLDo.
ANDA 70-190Naloxone HCl Injection USP, 0.4 mg/mLDo.
ANDA 70-191Naloxone HCl Injection USP, 0.4 mg/mLDo.
ANDA 70-480Leucovorin Calcium for Injection, 50 mgElkins Sinn, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
ANDA 70-917Nalbuphine HCl Injection, 20 mg/mLAbbott Laboratories
ANDA 72-639Metoclopramide HCl Tablets USP, 10 mgClonmel Healthcare Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512
ANDA 74-051Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mgApothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500
ANDA 74-211Naproxen Tablets USP, 250 mg, 375 mg, and 500 mgRoxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216
ANDA 74-257Naproxen Sodium Tablets USPDo.
ANDA 80-454Meperidine HCl Tablets USP, 50 mgDo.
ANDA 80-553Thiamine HCl Injection USP, 100 mg/mLDo.
ANDA 80-554Cyanocobalamin Injection USPDo.
ANDA 80-577Diphenhydramine HCl Injection USP, 50 mg/mLDo.
ANDA 81-224Leucovorin Calcium for Injection, 100 mgElkins Sinn, c/o Wyeth Pharmaceuticals
ANDA 81-239Cycrin (medroxyprogesterone acetate) Tablets USP, 2.5 mgDo.
ANDA 81-240Cycrin (medroxyprogesterone) Tablets USP, 5 mgDo.
ANDA 83-159Calcium Gluceptate InjectionAbbott Laboratories
ANDA 83-262Secobarbital Sodium Injection USP, 50 mg/mLWyeth Pharmaceuticals
ANDA 83-640Quinidine Sulfate Tablets USP, 200 mgRoxane Laboratories, Inc.
ANDA 84-316Dimenhydrinate Injection USP, 50 mgWyeth Pharmaceuticals
ANDA 84-386Digoxin Injection USP, 500 micrograms/2 mLDo.
ANDA 84-445Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 3 CapsulesA. H. Robins Co.
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ANDA 84-446Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 4 CapsulesDo.
ANDA 85-328Theo-Dur (theophylline) Extended-Release Tablets, 100 mg and 300 mgSchering Corp.
ANDA 85-632Quinidine Sulfate Tablets USP, 300 mgRoxane Laboratories, Inc.
ANDA 86-134Nitro-Bid Ointment (nitroglycerin ointment USP, 2%)Altana Inc., 60 Baylis Rd., Melville, NY 11747
ANDA 86-348Prochlorperazine Edisylate Injection USP, 5 mg (base)/mLWyeth Pharmaceuticals
ANDA 86-998Theo-Dur (theophylline) Extended-Release Tablets, 200 mgSchering Corp.
ANDA 88-584DHCplus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules, 356.4 mgPurdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431
ANDA 89-116Brompheril (dexbrompheniramine maleate/ pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mgCopley Pharmaceuticals, Inc., c/o Teva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA 19454
ANDA 89-131Theo-Dur (theophylline) Extended-Release Tablets, 450 mgSchering Corp.
ANDA 89-386Cycrin (medroxyprogesterone acetate) Tablets, 10 mgWyeth Pharmaceuticals
ANDA 89-573Methylprednisolone Sodium Succinate for Injection USP, 40 mgAbbott Laboratories
ANDA 89-574Methylprednisolone Sodium Succinate for Injection USP, 125 mgDo.
ANDA 89-575Methylprednisolone Sodium Succinate for Injection USP, 500 mgDo.
ANDA 89-576Methylprednisolone Sodium Succinate for Injection USP, 1000 mgDo.
ANDA 89-822Uni-Dur (theophylline) Extended-Release Tablets, 400 mgSchering Corp.
ANDA 89-823Uni-Dur (theophylline) Extended-Release Tablets, 600 mgDo.

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 June 4, 2004.

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Dated: March 22, 2004.

Steven K. Galson,

Acting Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. 04-10194 Filed 5-4-04; 8:45 am]