65 FR 191 pgs. 58775-58777 - Apothecon, Inc., et al.; Withdrawal of Approval of 76 Abbreviated New Drug Applications
Type: NOTICEVolume: 65Number: 191Pages: 58775 - 58777
Docket number: [Docket No. 00N-1516]
FR document: [FR Doc. 00-24844 Filed 9-29-00; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1516]
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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 InhalationSolution USP), 5%. | Muro Pharmaceutical, Inc., 890 East St.,Tewksbury, MA 01876. |
| 74-361 | Cimetidine Tablets USP, 300 mg, 400 mg, and800 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/25mg. | 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 (PrednisoneTablets 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 andHydrochlorothiazide USP)Capsules, 100/50 mg. | Novartis PharmaceuticalsCorp. |
| 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 (MedroxyprogesteroneAcetate Tablets, USP) 10 mg. | Solvay Pharmaceuticals,Inc. |
| 85-733 | Hydrocortisone Cream USP, 1%. | Zenith GoldlinePharmaceuticals, Inc. |
| 85-777 | Selenium Sulfide Lotion USP, 2.5%. | Do. |
| 85-873 | Butabarbital Sodium Elixir, 30 mg/5 mL. | Alpharma. |
| 85-944 | AmitriptylineHydrochloride TabletsUSP, 25 mg. | Roxane Laboratories, Inc. |
| 85-945 | Amitriptyline Hydrochloride TabletsUSP, 50 mg. | Do. |
| 86-002 | Amitriptyline Hydrochloride TabletsUSP, 10 mg. | Do. |
| 86-003 | Amitriptyline Hydrochloride TabletsUSP, 100 mg. | Do. |
| 86-004 | Amitriptyline Hydrochloride TabletsUSP, 75 mg. | Do. |
| 86-065 | Procan SR (Procainamide Hydrochloride -Extended---Release -Tablets, USP),500 mg. | Parkedale Pharmaceuticals, Inc. |
| 86-090 | Amitriptyline Hydrochloride TabletsUSP, 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 TabletsUSP, 5 mg. | Zenith GoldlinePharmaceuticals, Inc. |
| 87-375 | Flutex (TriamcinoloneAcetonide Ointment USP). | Do. |
| 87-376 | Flutex (TriamcinoloneAcetonide Ointment USP). | Do. |
| 87-377 | Flutex (TriamcinoloneAcetonide 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 (TriamcinoloneAcetonide Cream USP),0.025%. | Do. |
| 87-510 | Procan SR (ProcainamideHydrochloride -Extended-Release -Tablets, USP),750 mg. | ParkedalePharmaceuticals, Inc. |
| 87-611 | Liquid Pred (PrednisoneSyrup USP), 5 mg/5 mL. | Muro Pharmaceutical, Inc. |
| 87-612 | TrifluoperazineHydrochloride Tablets USP, 1 mg. | Zenith GoldlinePharmaceuticals, Inc. |
| 87-613 | Trifluoperazine Hydrochloride Tablets USP, 2 mg. | Do. |
| 87-614 | TrifluoperazineHydrochloride TabletsUSP, 10 mg. | Do. |
| 87-742 | Oxycodone Hydrochloride2.25 mg, OxycodoneTerephthalate 0.19 mg, and Aspirin 325 mgTablets. | Roxane Laboratories, Inc. |
| 88-275 | Isoetharine InhalationSolution USP, 0.25%. | Do. |
| 88-489 | Procan SR (Procainamide Hydrochloride -Extended-Release -Tablets, USP),1 gram. | Parkedale Pharmaceuticals, Inc. |
| 89-193 | Methocarbamol and AspirinCoated Tablets, 400 mg/325 mg. | McNeil Consumer Healthcare,7050 Camp Hill Rd.,Fort Washington, PA19034-2299. |
| 89-427 | Dipyridamole Tablets USP,75 mg. | Purepac PharmaceuticalCo.,200 Elmora Ave.,Elizabeth, NJ 07207. |
| 89-614 | Isoetharine InhalationSolution 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