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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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.
60-100
| ANDA No. | Drug | Applicant |
|---|---|---|
| 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.
[FR Doc. 00-24844 Filed 9-29-00; 8:45 am]
BILLING CODE 4160-01-F