[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withdrawn.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.

 
----------------------------------------------------------------------------------------------------------------
                         ANDA No.                                                   Drug
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


[[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