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Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated New Drug Applications

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

October 10, 2000.

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FOR FURTHER INFORMATION CONTACT:

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

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

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 request, waived their opportunity for a hearing.

ANDA No.DrugApplicant
60-100Crysticillin (Penicillin G Procaine Suspension USP).Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543.
60-618Grifulvin V (Griseofluvin Microsize) Tablets, 125 milligrams (mg), 250 mg, and 500 mg.Johnson & Johnson Consumer Co, Inc., 199 Grandview Rd., Skillman, NJ 08858.
61-220Opthochlor (Chloramphenicol Ophthalmic Solution USP) 5 mg/milliliter (mL).Parkedale Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
61-334Bactocill (Oxacillin Sodium for Injection).SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101.
61-449Staphcillin (Methicillin Sodium).Apothecon, Inc.
61-452Cloxacillin Sodium Capsules USP, 250 mg and 500 mg.Do.
61-739Garamycin Pediatric Injection (Gentamicin Sulfate Injection USP).Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
62-328Erythromycin Topical Solution USP, 1.5%.Alpharma, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.
62-727Totacillin-N (Ampicillin Sodium) for Injection.Smithkline Beecham Pharmaceuticals.
62-755Nallpen (Nafcillin Sodium Powder for Injection USP).Do.
70-356Diazepam Tablets USP, 2 mg.Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216.
70-357Diazepam Tablets USP, 5 mg.Do.
70-358Diazepam Tablets USP, 10 mg.Do.
71-010Acetominophen Suppositories, 120 mg.Do.
71-011Acetominophen Suppositories, 650 mg.Do.
71-018Metaproterenol Sulfate Inhalation Solution USP, 0.6%.AstraZeneca, L.P.
71-275Metaproterenol Sulfate Inhalation Solution USP, 0.4%.Do.
72-018Droperidol Injection USP, 2.5 mg/mL.Do.
72-019Droperidol Injection USP, 2.5 mg/mL.Do.
72-021Droperidol Injection USP, 2.5 mg/mL.Do.
72-648Timolol Maleate Tablets USP, 5 mg.Novopharm Limited, c/o Novopharm NC, Inc., 4700 Novopharm Blvd., Wilson, NC 27893.
72-649Timolol Maleate Tablets USP, 10 mg.Do.
72-650Timolol Maleate Tablets USP, 20 mg.Do.
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73-187Loperamide Hydrochloride Oral Solution, 1 mg/5 mL.Alpharma.
73-340Prometa Inhalation Solution (Metaproternol Sulfate Inhalation Solution USP), 5%.Muro Pharmaceutical, Inc., 890 East St., Tewksbury, MA 01876.
74-361Cimetidine Tablets USP, 300 mg, 400 mg, and 800 mg.Roxane Laboratories, Inc.
74-371Cimetidine Tablets USP, 800 mg.Do.
74-790Ketorolac Tromethamine Tablets USP.Do.
74-832Captopril and Hydrochlorothiazide Tablets USP, 50 mg/25 mg.Danbury Pharmacal, Inc., 131 West St., Danbury, CT 06810.
80-001Calcium Gluceptate Injection USP.Abbott Laboratories.
80-327Prednisolone Tablets USP, 5 mg.Roxane Laboratories, Inc.
80-474Hytone (Hydrocortisone) Ointment 0.25%, 0.5%, 1%, and 2.5%.Dermik Laboratories, Inc., 500 Arcola Rd., P.O. Box 1200, Collegeville, PA 19426-0107.
83-682Phendimetrazine Tartrate Tablets USP, 35 mg.Zenith Goldline Pharmaceuticals, Inc., 140 Legerand Ave., Northvale, NJ 07647.
84-655Prednicen-M (Prednisone Tablets USP), 5 mg.Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201.
84-659Acetominophen and Codeine Phosphate Tablets USP, 300 mg/15 mg.Roxane Laboratories, Inc.
84-667Acetominophen and Codeine Phosphate Tablets USP, 300 mg/60 mg.Do.
84-811Apresazide (Hydralazine Hydrochloride and Hydrochlorothiazide USP) Capsules, 100/50 mg.Novartis Pharmaceuticals Corp.
84-990Dexone (Dexamethasone Tablets, USP), 1.5 mg.Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.
85-539Flutex (Triamcinolone Acetonide Cream USP), 0.1%, 0.5%, and 0.025%.Zenith Goldline Pharmaceuticals, Inc.
85-686Curretab (Medroxyprogesterone Acetate Tablets, USP) 10 mg.Solvay Pharmaceuticals, Inc.
85-733Hydrocortisone Cream USP, 1%.Zenith Goldline Pharmaceuticals, Inc.
85-777Selenium Sulfide Lotion USP, 2.5%.Do.
85-873Butabarbital Sodium Elixir, 30 mg/5 mL.Alpharma.
85-944Amitriptyline Hydrochloride Tablets USP, 25 mg.Roxane Laboratories, Inc.
85-945Amitriptyline Hydrochloride Tablets USP, 50 mg.Do.
86-002Amitriptyline Hydrochloride Tablets USP, 10 mg.Do.
86-003Amitriptyline Hydrochloride Tablets USP, 100 mg.Do.
86-004Amitriptyline Hydrochloride Tablets USP, 75 mg.Do.
86-065Procan SR (Procainamide Hydrochloride ­Extended­-­Release ­Tablets, USP), 500 mg.Parkedale Pharmaceuticals, Inc.
86-090Amitriptyline Hydrochloride Tablets USP, 150 mg.Roxane Laboratories, Inc.
87-025Isoetharine Inhalation Solution USP, 0.125%.Roxane Laboratories, Inc.
87-203Flurandrenolide Lotion USP.Alpharma.
87-328Trifluoperazine Hydrocholride Tablets USP, 5 mg.Zenith Goldline Pharmaceuticals, Inc.
87-375Flutex (Triamcinolone Acetonide Ointment USP).Do.
87-376Flutex (Triamcinolone Acetonide Ointment USP).Do.
87-377Flutex (Triamcinolone Acetonide Ointment USP).Do.
87-396Isoetharine Inhalation Solution USP, 0.1%.Roxane Laboratories, Inc.
87-427Nogenic HC (Hydrocortisone Cream USP), 1%.Zenith Goldline Pharmaceuticals, Inc.
87-428Triatex (Triamcinolone Acetonide Cream USP), 0.5%.Do.
87-429Triatex (Triamcinolone Acetonide Cream USP), 0.1%.Do.
87-430Triatex (Triamcinolone Acetonide Cream USP), 0.025%.Do.
87-510Procan SR (Procainamide Hydrochloride ­Extended-Release ­Tablets, USP), 750 mg.Parkedale Pharmaceuticals, Inc.
87-611Liquid Pred (Prednisone Syrup USP), 5 mg/5 mL.Muro Pharmaceutical, Inc.
87-612Trifluoperazine Hydrochloride Tablets USP, 1 mg.Zenith Goldline Pharmaceuticals, Inc.
87-613Trifluoperazine Hydrochloride Tablets USP, 2 mg.Do.
87-614Trifluoperazine Hydrochloride Tablets USP, 10 mg.Do.
87-742Oxycodone Hydrochloride 2.25 mg, Oxycodone Terephthalate 0.19 mg, and Aspirin 325 mg Tablets.Roxane Laboratories, Inc.
88-275Isoetharine Inhalation Solution USP, 0.25%.Do.
88-489Procan SR (Procainamide Hydrochloride ­Extended-Release ­Tablets, USP), 1 gram.Parkedale Pharmaceuticals, Inc.
89-193Methocarbamol and Aspirin Coated Tablets, 400 mg/325 mg.McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.
89-427Dipyridamole Tablets USP, 75 mg.Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.
89-614Isoetharine Inhalation Solution USP, 0.062%.AstraZeneca, L.P.
89-615Isoetharine Inhalation Solution USP, 0.125%.Do.
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89-616Isoetharine Inhalation Solution USP, 0.167%.Do.
89-617Isoetharine Inhalation Solution USP, 0.2%.Do.
89-618Isoetharine Inhalation Solution USP, 0.25%.Do.

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 (21 CFR 5.82), approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective October 10, 2000.

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Dated: September 12, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 00-24844 Filed 9-29-00; 8:45 am]

BILLING CODE 4160-01-F