00-24844. Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated New Drug Applications

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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.

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.

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.	Drug	Applicant
60-100	Crysticillin (Penicillin G Procaine Suspension USP).	Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543.
60-618	Grifulvin V (Griseofluvin Microsize) Tablets, 125 milligrams (mg), 250 mg, and 500 mg.	Johnson & Johnson Consumer Co, Inc., 199 Grandview Rd., Skillman, NJ 08858.
61-220	Opthochlor (Chloramphenicol Ophthalmic Solution USP) 5 mg/milliliter (mL).	Parkedale Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.
61-334	Bactocill (Oxacillin Sodium for Injection).	SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101.
61-449	Staphcillin (Methicillin Sodium).	Apothecon, Inc.
61-452	Cloxacillin Sodium Capsules USP, 250 mg and 500 mg.	Do.
61-739	Garamycin Pediatric Injection (Gentamicin Sulfate Injection USP).	Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
62-328	Erythromycin Topical Solution USP, 1.5%.	Alpharma, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.
62-727	Totacillin-N (Ampicillin Sodium) for Injection.	Smithkline Beecham Pharmaceuticals.
62-755	Nallpen (Nafcillin Sodium Powder for Injection USP).	Do.
70-356	Diazepam Tablets USP, 2 mg.	Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216.
70-357	Diazepam Tablets USP, 5 mg.	Do.
70-358	Diazepam Tablets USP, 10 mg.	Do.
71-010	Acetominophen Suppositories, 120 mg.	Do.
71-011	Acetominophen Suppositories, 650 mg.	Do.
71-018	Metaproterenol Sulfate Inhalation Solution USP, 0.6%.	AstraZeneca, L.P.
71-275	Metaproterenol Sulfate Inhalation Solution USP, 0.4%.	Do.
72-018	Droperidol Injection USP, 2.5 mg/mL.	Do.
72-019	Droperidol Injection USP, 2.5 mg/mL.	Do.
72-021	Droperidol Injection USP, 2.5 mg/mL.	Do.
72-648	Timolol Maleate Tablets USP, 5 mg.	Novopharm Limited, c/o Novopharm NC, Inc., 4700 Novopharm Blvd., Wilson, NC 27893.
72-649	Timolol Maleate Tablets USP, 10 mg.	Do.
72-650	Timolol Maleate Tablets USP, 20 mg.	Do.
73-187	Loperamide Hydrochloride Oral Solution, 1 mg/5 mL.	Alpharma.
73-340	Prometa Inhalation Solution (Metaproternol Sulfate Inhalation Solution USP), 5%.	Muro Pharmaceutical, Inc., 890 East St., Tewksbury, MA 01876.
74-361	Cimetidine Tablets USP, 300 mg, 400 mg, and 800 mg.	Roxane Laboratories, Inc.
74-371	Cimetidine Tablets USP, 800 mg.	Do.
74-790	Ketorolac Tromethamine Tablets USP.	Do.
74-832	Captopril and Hydrochlorothiazide Tablets USP, 50 mg/25 mg.	Danbury Pharmacal, Inc., 131 West St., Danbury, CT 06810.
80-001	Calcium Gluceptate Injection USP.	Abbott Laboratories.
80-327	Prednisolone Tablets USP, 5 mg.	Roxane Laboratories, Inc.
80-474	Hytone (Hydrocortisone) Ointment 0.25%, 0.5%, 1%, and 2.5%.	Dermik Laboratories, Inc., 500 Arcola Rd., P.O. Box 1200, Collegeville, PA 19426-0107.
83-682	Phendimetrazine Tartrate Tablets USP, 35 mg.	Zenith Goldline Pharmaceuticals, Inc., 140 Legerand Ave., Northvale, NJ 07647.
84-655	Prednicen-M (Prednisone Tablets USP), 5 mg.	Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201.
84-659	Acetominophen and Codeine Phosphate Tablets USP, 300 mg/15 mg.	Roxane Laboratories, Inc.
84-667	Acetominophen and Codeine Phosphate Tablets USP, 300 mg/60 mg.	Do.
84-811	Apresazide (Hydralazine Hydrochloride and Hydrochlorothiazide USP) Capsules, 100/50 mg.	Novartis Pharmaceuticals Corp.
84-990	Dexone (Dexamethasone Tablets, USP), 1.5 mg.	Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.
85-539	Flutex (Triamcinolone Acetonide Cream USP), 0.1%, 0.5%, and 0.025%.	Zenith Goldline Pharmaceuticals, Inc.
85-686	Curretab (Medroxyprogesterone Acetate Tablets, USP) 10 mg.	Solvay Pharmaceuticals, Inc.
85-733	Hydrocortisone Cream USP, 1%.	Zenith Goldline Pharmaceuticals, Inc.
85-777	Selenium Sulfide Lotion USP, 2.5%.	Do.
85-873	Butabarbital Sodium Elixir, 30 mg/5 mL.	Alpharma.
85-944	Amitriptyline Hydrochloride Tablets USP, 25 mg.	Roxane Laboratories, Inc.
85-945	Amitriptyline Hydrochloride Tablets USP, 50 mg.	Do.
86-002	Amitriptyline Hydrochloride Tablets USP, 10 mg.	Do.
86-003	Amitriptyline Hydrochloride Tablets USP, 100 mg.	Do.
86-004	Amitriptyline Hydrochloride Tablets USP, 75 mg.	Do.
86-065	Procan SR (Procainamide Hydrochloride ­Extended­-­Release ­Tablets, USP), 500 mg.	Parkedale Pharmaceuticals, Inc.
86-090	Amitriptyline Hydrochloride Tablets USP, 150 mg.	Roxane Laboratories, Inc.
87-025	Isoetharine Inhalation Solution USP, 0.125%.	Roxane Laboratories, Inc.
87-203	Flurandrenolide Lotion USP.	Alpharma.
87-328	Trifluoperazine Hydrocholride Tablets USP, 5 mg.	Zenith Goldline Pharmaceuticals, Inc.
87-375	Flutex (Triamcinolone Acetonide Ointment USP).	Do.
87-376	Flutex (Triamcinolone Acetonide Ointment USP).	Do.
87-377	Flutex (Triamcinolone Acetonide Ointment USP).	Do.
87-396	Isoetharine Inhalation Solution USP, 0.1%.	Roxane Laboratories, Inc.
87-427	Nogenic HC (Hydrocortisone Cream USP), 1%.	Zenith Goldline Pharmaceuticals, Inc.
87-428	Triatex (Triamcinolone Acetonide Cream USP), 0.5%.	Do.
87-429	Triatex (Triamcinolone Acetonide Cream USP), 0.1%.	Do.
87-430	Triatex (Triamcinolone Acetonide Cream USP), 0.025%.	Do.
87-510	Procan SR (Procainamide Hydrochloride ­Extended-Release ­Tablets, USP), 750 mg.	Parkedale Pharmaceuticals, Inc.
87-611	Liquid Pred (Prednisone Syrup USP), 5 mg/5 mL.	Muro Pharmaceutical, Inc.
87-612	Trifluoperazine Hydrochloride Tablets USP, 1 mg.	Zenith Goldline Pharmaceuticals, Inc.
87-613	Trifluoperazine Hydrochloride Tablets USP, 2 mg.	Do.
87-614	Trifluoperazine Hydrochloride Tablets USP, 10 mg.	Do.
87-742	Oxycodone Hydrochloride 2.25 mg, Oxycodone Terephthalate 0.19 mg, and Aspirin 325 mg Tablets.	Roxane Laboratories, Inc.
88-275	Isoetharine Inhalation Solution USP, 0.25%.	Do.
88-489	Procan SR (Procainamide Hydrochloride ­Extended-Release ­Tablets, USP), 1 gram.	Parkedale Pharmaceuticals, Inc.
89-193	Methocarbamol and Aspirin Coated Tablets, 400 mg/325 mg.	McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299.
89-427	Dipyridamole Tablets USP, 75 mg.	Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ 07207.
89-614	Isoetharine Inhalation Solution USP, 0.062%.	AstraZeneca, L.P.
89-615	Isoetharine Inhalation Solution USP, 0.125%.	Do.
89-616	Isoetharine Inhalation Solution USP, 0.167%.	Do.
89-617	Isoetharine Inhalation Solution USP, 0.2%.	Do.
89-618	Isoetharine 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.

Dated: September 12, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.