[Federal Register Volume 59, Number 201 (Wednesday, October 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25909]
[[Page Unknown]]
[Federal Register: October 19, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0369]
King Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27
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 27 abbreviated new drug applications (ANDA's). The holders of the
ANDA's 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withdrawn.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: November 18, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-360), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: The holders of the ANDA's 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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70-106.................. Metoclopramide King Pharmaceuticals,
Tablets, U.S.P., 10 Inc., 501 Fifth St.,
milligrams (mg). Bristol, TN 37620.
70-484.................. Betamethasone Valerate Pharmafair, Inc., 110
Lotion, U.S.P., 0.1%. Kennedy Dr.,
Hauppauge, NY 11788.
72-817.................. Albuterol Tablets, Warner Chilcott
U.S.P., 2 mg. Laboratories, 201
Tabor Rd., Morris
Plains, NJ 07950.
72-818.................. Albuterol Tablets, Do.
U.S.P., 4 mg.
80-635.................. Diphenhydramine Roxane Laboratories,
Hydrochloride Inc., P.O. Box 16532,
Capsules, U.S.P., 50 Colombus, OH 43216-
mg. 6532.
80-731.................. Cortisone Acetate Inwood Laboratories,
Tablets, U.S.P., 25 Inc., 300 Prospect
mg. St., Inwood, NY
11896.
80-732.................. Hydrocortisone Do.
Tablets, U.S.P., 20
mg.
80-932.................. Propylthiouracil Danbury Pharmacal,
Tablets, U.S.P., 50 Inc., 131 West St.,
mg. Danbury, CT 06810.
85-902.................. Homatropine Lemmon Co., 650
Methylbromide Cathill Rd.,
Tablets, U.S.P., 10 Sellersville, PA
mg. 18960.
86-610.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 10
mg.
86-853.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 150
mg.
86-854.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 100
mg.
86-857.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 50
mg.
86-859.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 25
mg.
86-860.................. Amitriptyline Do.
Hydrochloride
Tablets, U.S.P., 75
mg.
87-838.................. Hydrocortisone Cream, Pharmafair, Inc.
U.S.P., 1%.
88-150.................. Cyclopentolate Do.
Hydrochloride
Ophthalmic Solution,
U.S.P., 1%.
88-274.................. Tropicamide Ophthalmic Do.
Solution, U.S.P.,
0.5%.
88-433.................. Dexamethasone Sodium Do.
Phosphate Ophthalmic,
Solution, U.S.P.,
0.1%.
88-560.................. Hydralazine Amide Pharmaceutical,
Hydrochloride Inc., 101 East Main
Tablets, U.S.P.. St., Little Falls, NJ
07424.
88-643.................. Cyclopentolate Pharmafair, Inc.
Hydrochloride
Ophthalmic Solution,
U.S.P., 0.5%.
88-649.................. Hydralazine Amide Pharmaceutical,
Hydrochloride Inc.
Tablets, U.S.P..
88-713.................. Hydroxyzine Pamoate Lemmon Co.
Capsules, U.S.P., 25
mg.
88-746.................. Theophylline Syrup, Marion Merrell Dow,
150 mg/15 milliliters. Inc., P.O. Box 9627,
Kansas City, MO 64134-
0627.
88-947.................. Sulfacetamide Sodium Pharmafair, Inc.
10% with
Hydroxyethylcellulose
Ophthalmic Solution.
89-115.................. Butalbital, Krebs and Associates,
Acetaminophen, and P.C., For U.S.
Caffeine Capsules, Pharmaceutical Corp.,
U.S.P., 50 mg/325 mg/ 2401-C Mellon Ct.,
40 mg. Decatur, GA 30035.
89-360.................. Hydrocodone Bitartrate Central
and Acetaminophen Pharmaceuticals,
Capsules, U.S.P., 5 Inc., 120 East Third
mg/500 mg. St., P.O. Box 328,
Seymour, IN 47274-
0328.
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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 ANDA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective November 18, 1994.
Dated: October 4, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-25909 Filed 10-18-94; 8:45 am]
BILLING CODE 4160-01-F
