[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64266-64268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30878]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-1000]
Danbury Pharmacal, Inc.; Withdrawal of Approval of 61 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 61 abbreviated new drug applications (ANDA's). Danbury Pharmacal,
Inc., 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withdrawn.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: December 21, 1998.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
[[Page 64267]]
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION: Danbury Pharmacal, Inc., 131 West St.,
Danbury, CT 16810, has informed FDA that the drug products listed in
the following table are no longer marketed and has requested that FDA
withdraw approval of the applications. Danbury Pharmacal, Inc., has
also, by its request, waived its opportunity for a hearing.
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ANDA No. Drug
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63-082................................................... Clindamycin Hydrochloride Capsules USP, 75 milligrams
(mg)
71-098................................................... Propranolol Hydrochloride Tablets USP, 60 mg
71-183................................................... Propranolol Hydrochloride Tablets USP, 90 mg
71-494................................................... Oxazepam Tablets USP, 15 mg
71-498................................................... Propranolol Hydrochloride and Hydrochlorothiazide
Tablets USP, 40 mg/25 mg
71-501................................................... Propranolol Hydrochloride and Hydrochlorothiazide
Tablets USP, 80 mg/25 mg
71-905................................................... Ibuprofen Tablets USP, 200 mg
72-113................................................... Haloperidol Tablets USP, 10 mg
72-134................................................... Perphenazine and Amitriptyline Hydrochloride Tablets
USP, 4 mg/25 mg
72-135................................................... Perphenazine and Amitriptyline Hydrochloride Tablets
USP, 4 mg/50 mg
72-353................................................... Haloperidol Tablets USP, 20 mg
72-539................................................... Perphenazine and Amitriptyline Hydrochloride Tablets
USP, 2 mg/10 mg
72-540................................................... Perphenazine and Amitriptyline Hydrochloride Tablets
USP, 4 mg/10 mg
72-541................................................... Perphenazine and Amitriptyline Hydrochloride Tablets
USP, 2 mg/25 mg
72-981................................................... Fenoprofen Calcium Capsules USP
72-982................................................... Fenoprofen Calcium Capsules USP
72-996................................................... Indomethacin Capsules USP, 25 mg
72-997................................................... Indomethacin Capsules USP, 50 mg
80-393................................................... Reserpine Tablets USP, 0.25 mg
80-522................................................... Isoniazid Tablets USP, 50 mg
80-523................................................... Isoniazid Tablets USP, 100 mg
80-679................................................... Reserpine Tablets USP, 0.1 mg
80-696................................................... Chlorpheniramine Maleate Tablets USP, 4 mg
80-749................................................... Reserpine Tablets USP, 1 mg
80-905................................................... Phenytoin Sodium Capsules USP, 100 mg
80-907................................................... Rauwolfia Serpentina Tablets USP, 50 mg
80-908................................................... Propoxyphene Hydrochloride Capsules USP, 65 mg
80-914................................................... Rauwolfia Serpentina Tablets USP, 100 mg
83-029................................................... Propantheline Bromide Tablets USP, 15 mg
83-123................................................... Brompheniramine Maleate Tablets USP, 4 mg
83-305................................................... Niacin Tablets USP, 500 mg
83-712................................................... Promethazine Hydrochloride Tablets USP, 12.5 mg
83-847................................................... Trichlormathiazide Tablets USP, 2 mg
83-855................................................... Trichlormethiazide Tablets USP, 4 mg
84-274................................................... Meprobamate Tablets USP, 600 mg
84-347................................................... Dicyclomine Hydrochloride Capsules USP, 10 mg
84-362................................................... Glutethimide Tablets USP, 500 mg
84-*402.................................................. Bethanechol Chloride Tablets USP, 5 mg
84-602................................................... Dicyclomine Hydrochloride Tablets USP, 20 mg
85-094................................................... Triprolidine Hydrochloride Tablets USP, 2.5 mg
85-584................................................... Quinidine Sulfate Tablets USP, 100 mg
86-086................................................... Pentaerythritol Tetranitrate Tablets USP, 20 mg
86-580................................................... Cyproheptadine Hydrochloride Tablets USP, 4 mg
86-900................................................... Glycopyrrolate Tablets USP, 2 mg
86-901................................................... Chlorzoxazone Tablets USP, 250 mg
86-902................................................... Glycopyrrolate Tablets USP, 1 mg
87-419................................................... Dipyridamole Tablets USP, 25 mg
87-432................................................... Dipyridamole Tablets USP, 75 mg
87-550................................................... Butalbital and Acetaminophen, 50 mg/325 mg
87-667................................................... Sulfinpyrazone Tablets USP, 100 mg
87-767................................................... Hydroxyzine Pamoate Capsules USP (equivalent to 50 mg
Hydroxyzine Hydrochloride)
87-790................................................... Hydroxyzine Pamoate Capsules USP (equivalent to 100
mg Hydroxyzine Hydrochloride)
87-874................................................... Carisoprodol Compound Tablets
88-620................................................... Amitriptyline Hydrochloride Tablets USP, 10 mg
88-621................................................... Amitriptyline Hydrochloride Tablets USP, 25 mg
88-622................................................... Amitriptyline Hydrochloride Tablets USP, 50 mg
88-633................................................... Amitriptyline Hydrochloride Tablets USP, 75 mg
88-634................................................... Amitriptyline Hydrochloride Tablets USP, 100 mg
88-635................................................... Amitriptyline Hydrochloride Tablets USP, 150 mg
88-755................................................... Thioridazine Hydrochloride Tablets USP, 25 mg
88-800................................................... Dipyridamole Tablets USP, 50 mg
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[[Page 64268]]
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
December 21, 1998.
Dated: November 4, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-30878 Filed 11-18-98; 8:45 am]
BILLING CODE 4160-01-F