[Federal Register Volume 62, Number 6 (Thursday, January 9, 1997)]
[Notices]
[Pages 1337-1338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0003]
Hoffman-LaRoche, Inc., et al.; Withdrawal of Approval of 11 New
Drug Applications, 1 Abbreviated Antibiotic Application, and 20
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 11 new drug applications (NDA's), 1 abbreviated antibiotic
application (AADA), and 20 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of the applications be withdrawn.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: February 10, 1997.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
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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Application no. Drug Applicant
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NDA 6-525....................... Gantrisin Hoffman-La Roche,
(sulfisoxazole) Inc., 340
Tablets. Kingsland St.,
Bldg. 719-4,
Nutley, NJ 07110.
NDA 12-486...................... Taractan Do.
(chlorprothixene)
Tablets.
NDA 12-772...................... Haldrone Eli Lilly and Co.,
(paramethasone Lilly Corporate
acetate) Tablets. Center,
Indianapolis, IN
46285.
[[Page 1338]]
NDA 12-966...................... Masterone Hoffman-La Roche,
(dromostanolone Inc.
propionate).
NDA 13-071...................... Libritabs Do.
(chlordiazepoxide
) Tablets, 5, 10,
25 milligrams
(mg).
NDA 13-664...................... GANTANOL Do.
(sulfamethoxazole
) Suspension.
NDA 16-109...................... Sinubid Parke-Davis, 2800
(acetaminophen, Plymouth Rd., Ann
phenylpropanolami Arbor, MI 48105.
ne HCl, and
phenyltoloxamine
citrate) Extended
Release Tablets.
NDA 16-943...................... Halotex Westwood-Squibb
(haloprogin) 1% Pharmaceuticals,
Solution. Inc.,100 Forest
Ave., Buffalo, NY
14213-1091.
NDA 17-914...................... OTIC-TRIDESILON Bayer Corp., 400
(desonide-acetic Morgan Ln., West
acid) Solution Haven, CT 06516-
0.05%. 4175.
NDA 18-366...................... Chymex Savage
(bentiromide) Laboratories,
Solution. Division of
Altana, Inc., 60
Baylis Rd.,
Melville, NY
11747.
NDA 18-470...................... Cibacalcin Ciba-Geigy Corp.,
(calcitonin- Summit, NJ 07901.
human, for
injection).
AADA 62-078..................... Ampicillin Sandoz
Trihydrate (bulk). Pharmaceuticals,
59 Route 10, East
Hanover, NJ07936-
1080.
ANDA 70-120..................... Propranolol Schering Corp.,
Hydrochloride 2000 Galloping
Tablets, 10 mg. Hill Rd.,
Kenilworth, NJ
07033.
ANDA 70-121..................... Propranolol Do.
Hydrochloride
Tablets, 20 mg.
ANDA 70-122..................... Propranolol Do.
Hydrochloride
Tablets, 40 mg.
ANDA 70-123..................... Propranolol Do.
Hydrochloride
Tablets, 60 mg.
ANDA 70-124..................... Propranolol Do.
Hydrochloride
Tablets, 80 mg.
ANDA 85-288..................... Acetaminophen and KV Pharmaceutical
Codeine Phosphate Co., 2503 South
Tablets USP, 300 Hanley Rd., St.
mg/30 mg. Louis, MO 63144-
2555.
ANDA 85-484..................... Chlorpromazine Do.
Hydrochloride
Tablets, USP, 50
mg.
ANDA 85-748..................... Chlorpromazine Do.
Hydrochloride
Tablets, USP, 200
mg.
ANDA 85-750..................... Chlorpromazine Do.
Hydrochloride
Tablets, USP, 10
mg.
ANDA 85-751..................... Chlorpromazine Do.
Hydrochloride
Tablets, USP, 25
mg.
ANDA 85-752..................... Chlorpromazine Do.
Hydrochloride
Tablets, USP, 100
mg.
ANDA 87-819..................... Hydroxyzine Do.
Hydrochloride
Tablets, USP, 10
mg.
ANDA 87-820..................... Hydroxyzine Do.
Hydrochloride
Tablets, USP, 25
mg.
ANDA 87-821..................... Hydroxyzine Do.
Hydrochloride
Tablets, USP, 50
mg.
ANDA 87-822..................... Hydroxyzine Do.
Hydrochloride
Tablets, USP, 100
mg.
ANDA 88-344..................... Triprolidine H. R. Cenci
Hydrochloride Laboratories,
Pseudoephedrine Inc., P.O. Box
Hydrochloride 12524, Fresno, CA
Syrup, 1.25 mg/30 93778-2524.
mg per 5
milliliters (mL).
ANDA 88-814..................... Promethazine with Do.
Codeine Syrup
(Promethazine
Hydrochloride and
Codeine Phosphate
Oral Solution,
6.25 mg/10 mg/5
mL).
ANDA 88-815..................... Promethazine VC Do.
Plain Syrup
(Promethazine
Hydrochloride and
Phenylephrine
Hydrochloride
Oral Solution,
6.25 mg/5 mg/5
mL).
ANDA 88-816..................... Promethazine Do.
Hydrochloride,
Phenylephrine
Hydrochloride,
Codeine Phospate
Syrup, 6.25 mg/5
mg/10 mg per 5 mL.
ANDA 89-018..................... Triprolidine Do.
Hydrochloride
Pseudoephedrine
Hydrochloride and
Codeine Phosphate
Cough Syrup, 1.25
mg/30 mg/10 mg
per 5 mL.
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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
February 10, 1997.
Dated: December 30, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-524 Filed 1-8-97; 8:45 am]
BILLING CODE 4160-01-F