[Federal Register: October 2, 2000 (Volume 65, Number 191)]
[Notices]
[Page 58775-58777]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc00-87]
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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.
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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be withdrawn.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.
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ANDA No. Drug Applicant
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60-100 Crysticillin (Penicillin Apothecon, Inc., P.O. Box 4500,
G Procaine Suspension Princeton, NJ 08543.
USP).
60-618 Grifulvin V (Griseofluvin Johnson & Johnson Consumer Co,
Microsize) Tablets, 125 Inc., 199 Grandview Rd.,
milligrams (mg), 250 mg, Skillman, NJ 08858.
and 500 mg.
61-220 Opthochlor Parkedale Pharmaceuticals, Inc.,
(Chloramphenicol 501 Fifth St., Bristol, TN
Ophthalmic Solution USP) 37620.
5 mg/milliliter (mL).
61-334 Bactocill (Oxacillin SmithKline Beecham
Sodium for Injection). Pharmaceuticals, One Franklin
Plaza, P.O. Box 7929,
Philadelphia, PA 19101.
61-449 Staphcillin (Methicillin Apothecon, Inc.
Sodium).
61-452 Cloxacillin Sodium Do.
Capsules USP, 250 mg and
500 mg.
61-739 Garamycin Pediatric Schering Corp., 2000 Galloping
Injection (Gentamicin Hill Rd., Kenilworth, NJ 07033.
Sulfate Injection USP).
62-328 Erythromycin Topical Alpharma, 333 Cassell Dr., suite
Solution USP, 1.5%. 3500, Baltimore, MD 21224.
62-727 Totacillin-N (Ampicillin Smithkline Beecham
Sodium) for Injection. Pharmaceuticals.
62-755 Nallpen (Nafcillin Sodium Do.
Powder for Injection
USP).
70-356 Diazepam Tablets USP, 2 Roxane Laboratories, Inc., P.O.
mg. Box 16532, Columbus, OH 43216.
70-357 Diazepam Tablets USP, 5 Do.
mg.
70-358 Diazepam Tablets USP, 10 Do.
mg.
71-010 Acetominophen Do.
Suppositories, 120 mg.
71-011 Acetominophen Do.
Suppositories, 650 mg.
71-018 Metaproterenol Sulfate AstraZeneca, L.P.
Inhalation Solution USP,
0.6%.
71-275 Metaproterenol Sulfate Do.
Inhalation Solution USP,
0.4%.
72-018 Droperidol Injection USP, Do.
2.5 mg/mL.
72-019 Droperidol Injection USP, Do.
2.5 mg/mL.
72-021 Droperidol Injection USP, Do.
2.5 mg/mL.
72-648 Timolol Maleate Tablets Novopharm Limited, c/o Novopharm
USP, 5 mg. NC, Inc., 4700 Novopharm Blvd.,
Wilson, NC 27893.
72-649 Timolol Maleate Tablets Do.
USP, 10 mg.
72-650 Timolol Maleate Tablets Do.
USP, 20 mg.
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73-187 Loperamide Hydrochloride Alpharma.
Oral Solution, 1 mg/5
mL.
73-340 Prometa Inhalation Muro Pharmaceutical, Inc., 890
Solution (Metaproternol East St., Tewksbury, MA 01876.
Sulfate Inhalation
Solution USP), 5%.
74-361 Cimetidine Tablets USP, Roxane Laboratories, Inc.
300 mg, 400 mg, and 800
mg.
74-371 Cimetidine Tablets USP, Do.
800 mg.
74-790 Ketorolac Tromethamine Do.
Tablets USP.
74-832 Captopril and Danbury Pharmacal, Inc., 131 West
Hydrochlorothiazide St., Danbury, CT 06810.
Tablets USP, 50 mg/25
mg.
80-001 Calcium Gluceptate Abbott Laboratories.
Injection USP.
80-327 Prednisolone Tablets USP, Roxane Laboratories, Inc.
5 mg.
80-474 Hytone (Hydrocortisone) Dermik Laboratories, Inc., 500
Ointment 0.25%, 0.5%, Arcola Rd., P.O. Box 1200,
1%, and 2.5%. Collegeville, PA 19426-0107.
83-682 Phendimetrazine Tartrate Zenith Goldline Pharmaceuticals,
Tablets USP, 35 mg. Inc., 140 Legerand Ave.,
Northvale, NJ 07647.
84-655 Prednicen-M (Prednisone Schwarz Pharma, Inc., P.O. Box
Tablets USP), 5 mg. 2038, Milwaukee, WI 53201.
84-659 Acetominophen and Codeine Roxane Laboratories, Inc.
Phosphate Tablets USP,
300 mg/15 mg.
84-667 Acetominophen and Codeine Do.
Phosphate Tablets USP,
300 mg/60 mg.
84-811 Apresazide (Hydralazine Novartis Pharmaceuticals Corp.
Hydrochloride and
Hydrochlorothiazide USP)
Capsules, 100/50 mg.
84-990 Dexone (Dexamethasone Solvay Pharmaceuticals, Inc., 901
Tablets, USP), 1.5 mg. Sawyer Rd., Marietta, GA 30062.
85-539 Flutex (Triamcinolone Zenith Goldline Pharmaceuticals,
Acetonide Cream USP), Inc.
0.1%, 0.5%, and 0.025%.
85-686 Curretab Solvay Pharmaceuticals, Inc.
(Medroxyprogesterone
Acetate Tablets, USP) 10
mg.
85-733 Hydrocortisone Cream USP, Zenith Goldline Pharmaceuticals,
1%. Inc.
85-777 Selenium Sulfide Lotion Do.
USP, 2.5%.
85-873 Butabarbital Sodium Alpharma.
Elixir, 30 mg/5 mL.
85-944 Amitriptyline Roxane Laboratories, Inc.
Hydrochloride Tablets
USP, 25 mg.
85-945 Amitriptyline Do.
Hydrochloride Tablets
USP, 50 mg.
86-002 Amitriptyline Do.
Hydrochloride Tablets
USP, 10 mg.
86-003 Amitriptyline Do.
Hydrochloride Tablets
USP, 100 mg.
86-004 Amitriptyline Do.
Hydrochloride Tablets
USP, 75 mg.
86-065 Procan SR (Procainamide Parkedale Pharmaceuticals, Inc.
Hydrochloride Extended-
Release Tablets, USP),
500 mg.
86-090 Amitriptyline Roxane Laboratories, Inc.
Hydrochloride Tablets
USP, 150 mg.
87-025 Isoetharine Inhalation Roxane Laboratories, Inc.
Solution USP, 0.125%.
87-203 Flurandrenolide Lotion Alpharma.
USP.
87-328 Trifluoperazine Zenith Goldline Pharmaceuticals,
Hydrocholride Tablets Inc.
USP, 5 mg.
87-375 Flutex (Triamcinolone Do.
Acetonide Ointment USP).
87-376 Flutex (Triamcinolone Do.
Acetonide Ointment USP).
87-377 Flutex (Triamcinolone Do.
Acetonide Ointment USP).
87-396 Isoetharine Inhalation Roxane Laboratories, Inc.
Solution USP, 0.1%.
87-427 Nogenic HC Zenith Goldline Pharmaceuticals,
(Hydrocortisone Cream Inc.
USP), 1%.
87-428 Triatex (Triamcinolone Do.
Acetonide Cream USP),
0.5%.
87-429 Triatex (Triamcinolone Do.
Acetonide Cream USP),
0.1%.
87-430 Triatex (Triamcinolone Do.
Acetonide Cream USP),
0.025%.
87-510 Procan SR (Procainamide Parkedale Pharmaceuticals, Inc.
Hydrochloride Extended-
Release Tablets, USP),
750 mg.
87-611 Liquid Pred (Prednisone Muro Pharmaceutical, Inc.
Syrup USP), 5 mg/5 mL.
87-612 Trifluoperazine Zenith Goldline Pharmaceuticals,
Hydrochloride Tablets Inc.
USP, 1 mg.
87-613 Trifluoperazine Do.
Hydrochloride Tablets
USP, 2 mg.
87-614 Trifluoperazine Do.
Hydrochloride Tablets
USP, 10 mg.
87-742 Oxycodone Hydrochloride Roxane Laboratories, Inc.
2.25 mg, Oxycodone
Terephthalate 0.19 mg,
and Aspirin 325 mg
Tablets.
88-275 Isoetharine Inhalation Do.
Solution USP, 0.25%.
88-489 Procan SR (Procainamide Parkedale Pharmaceuticals, Inc.
Hydrochloride Extended-
Release Tablets, USP), 1
gram.
89-193 Methocarbamol and Aspirin McNeil Consumer Healthcare, 7050
Coated Tablets, 400 mg/ Camp Hill Rd., Fort Washington,
325 mg. PA 19034-2299.
89-427 Dipyridamole Tablets USP, Purepac Pharmaceutical Co., 200
75 mg. Elmora Ave., Elizabeth, NJ
07207.
89-614 Isoetharine Inhalation AstraZeneca, L.P.
Solution USP, 0.062%.
89-615 Isoetharine Inhalation Do.
Solution USP, 0.125%.
[[Page 58777]]
89-616 Isoetharine Inhalation Do.
Solution USP, 0.167%.
89-617 Isoetharine Inhalation Do.
Solution USP, 0.2%.
89-618 Isoetharine Inhalation Do.
Solution USP, 0.25%.
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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