Human drugs: New drug applications— Danbury Pharmacal, Inc.; approval withdrawn,

[Federal Register: November 19, 1998 (Volume 63, Number 223)]

[Notices]

[Page 64266-64268]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19no98-77]

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.

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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

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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

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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 December 21, 1998.

Dated: November 4, 1998. Janet Woodcock, Director, Center for Drug Evaluation and Research.

[FR Doc. 98-30878Filed11-18-98; 8:45 am]

BILLING CODE 4160-01-F