[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7203]
[Federal Register: March 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0107]
Chelsea Laboratories, Inc.; Withdrawal of Approval of 26
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 26 abbreviated new drug applications (ANDA's) held by Chelsea
Laboratories, Inc., 896 Orlando Ave., West Hempstead, NY 11552
(Chelsea). Chelsea 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applications be withdrawn.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: April 27, 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: Chelsea informed FDA that the drugs listed
in the table in this document are no longer marketed and requested that
FDA withdraw approval of the applications. Chelsea has also, by its
request, waived its opportunity for a hearing.
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ANDA no. Drug
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70-000 Sulfamethoxazole and Trimethoprim
Tablets, U.S.P, 800 milligrams
(mg)/160 mg
70-002 Sulfamethoxazole and Trimethoprim
Tablets, U.S.P, 400 mg/80 mg
71-603 Clofibrate Capsules, U.S.P., 500 mg
71-635 Indomethacin Capsules, 50 mg
85-167 Procainamide Hydrochloride
Capsules, U.S.P., 250 mg
85-815 Amitriptyline Hydrochloride
Tablets, 50 mg
85-816 Amitriptyline Hydrochloride
Tablets, 10 mg
85-817 Amitriptyline Hydrochloride
Tablets, 25 mg
85-819 Amitriptyline Hydrochloride
Tablets, 75 mg
85-820 Amitriptyline Hydrochloride
Tablets, 100 mg
86-150 Probenecid Tablets, 500 mg
86-151 Phenylbutazone Tablets, U.S.P., 100
mg
86-161 Methylprednisolone Tablets, 4 mg
86-237 Butalbital, Aspirin, and Caffeine
Tablets, U.S.P., 50 mg/325 mg/40
mg
86-705 Hydroxyzine Pamoate Capsules,
U.S.P., 50 mg
86-827 Hydroxyzine Hydrochloride Tablets,
U.S.P., 10 mg
86-829 Hydroxyzine Hydrochloride Tablets,
U.S.P., 25 mg
86-836 Hydroxyzine Hydrochloride Tablets,
U.S.P., 50 mg
86-840 Hydroxyzine Pamoate Capsules,
U.S.P., 25 mg
86-865 Chlorpropamide Tablets, 100 mg
87-020 Procainamide Hydrochloride
Capsules, U.S.P., 375 mg
87-021 Procainamide Hydrochloride
Capsules, U.S.P., 500 mg
87-078 Spironolactone Tablets, 25 mg
87-082 Chlorthalidone Tablets, 50 mg
87-756 Phenylbutazone Capsules, U.S.P.,
100 mg
87-785 Quinidine Gluconate Sustained
Release Tablets, U.S.P., 324 mg
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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 April 27, 1994.
Dated: March 14, 1994.
Roger Williams,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7203 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F