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 Department of Health and Human Services Food and Drug Administration [Docket No. 00N-1516]
 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
Applicant60-100
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.( print page 58776)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.( print page 58777)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.


[FR Doc. 00-24844 Filed 9-29-00; 8:45 am] BILLING CODE 4160-01-F