Reference Listed Drug Labeling Approved in August 1999

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FDA/Center for Drug Evaluation and Research

Reference Listed Drug Labeling Approved in August 1999

Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes. Click on the product name to view the approved labeling changes in Adobe Acrobat format.

Product Name	Drug Name	NDA No	Supp.No	Firm	Date
LARIAM	Mefloquine HCl Tablets	19-591	S-012	Roche	02-Aug-1999
PROSCAR	Finasteride Tablets	20-180	S-018	Merck	02-Aug-1999
CEFOTAN	Cefatetan Disodium	50-588	S-026	Zeneca	05-Aug-1999
MARINOL	Dronabinol Capsules	18-651	S-011	Unimed	05-Aug-1999
ZOCOR	Simvastatin Tablets	19-766	S-032	Merck	05-Aug-1999
GLUCOTROL	Glipizide Tablets	17-783	S-015	Pfizer	06-Aug-1999
PROLOPRIM	Trimethoprim Tablets	17-943	S-015	Monarch Pharms	06-Aug-1999
PRANDIN	Repaglinide Tablets	20-741	S-001	Novo Nordisk Pharm	10-Aug-1999
DROXIA	Hydroxyurea Capsules	16-295	S-026	Bristol Myers Squibb	11-Aug-1999
HYDREA	Hydroxyurea Capsules	16-295	S-026	Bristol Myers Squibb	11-Aug-1999
IDAMYCIN PFS	Idarubicin HCl Injection	50-734	S-004	Pharmacia &Upjohn	12-Aug-1999
AZULFIDINE	Sulfasalazine Tablets	07-073	S-110	Pharmacia & Upjohn	13-Aug-1999
AZULFIDINE EN-TABS	Sulfasalazine Tablets	07-073	S-110	Pharmacia &Upjohn	13-Aug-1999
PREPIDIL	Dinoprostone Gel	19-617	S-002	Pharmacia &Upjohn	13-Aug-1999
ZAROXOLYN	Metolazone Tablets	17-386	S-030	Medeva Pharms	13-Aug-1999
RESCRIPTOR	Delavirdine Mesylate Tablets	20-705	S-004	Pharmacia &Upjohn	16-Aug-1999
BENTYL	Dicyclomine HCl Injection	08-370	S-028	Hoechst Marion Rssl	17-Aug-1999
BENTYL	Dicyclomine HCl Syrup	07-961	S-025	Hoechst Marion Rssl	17-Aug-1999
BENTYL	Dicyclomine HCl Tablets	07-409	S-039	Hoechst Marion Rssl	17-Aug-1999
DERMA-SMOOTHE/FS	Fluocinolone Acetonide Sol.	19-452	S-015	Hill Derm	18-Aug-1999
EULEXIN	Flutamide Capsules	18-554	S-015	Schering	19-Aug-1999
MEPERGAN	Meperidine HCl/Promethazine HCl	11-730	S-023	Wyeth Ayerst Labs	19-Aug-1999
ALDOCLOR-250	Methyldopa/Chlorthiazide Tablets	16-016	S-070	Merck	22-Aug-1999
INDERAL	Propranolol HCl Tablets	16-418	S-071	Wyeth Ayerst Labs	22-Aug-1999
INDERAL	Propranolol HCl Injection	16-419	S-022	Wyeth Ayerst Labs	22-Aug-1999
INDERAL LA	Propranolol HCl Extended-release Capsules	18-553	S-027	Wyeth Ayerst Labs	22-Aug-1999
SECTRAL	Acebutolol Capsules	18-917	S-020	Wyeth Ayerst Labs	22-Aug-1999
BETAPACE	Sotalol HCl Tablets	19-865	S-008	Berlex Labs	23-Aug-1999
TESLAC	Testolactone Tablets	16-118	S-020	Bristol Myers Squibb	24-Aug-1999
BLENOXANE	Bleomycin sulfate injection	50-443	S-028	Bristol Myers Squibb	25-Aug-1999
FURADANTIN	Nitrofurantoin oral suspension	09-175	S-026	Dura	25-Aug-1999
ONCOVIN	Vincristine sulfate injection	14-103	S-060	Lilly	26-Aug-1999
CORTISPORIN OTIC	Neomycin & polymixin B sulfates/hydrocortisone otic solution	50-479	S-015	King Pharmaceuticals	26-Aug-1999
BRETYLIUM	Bretylium tosylate injection	19-033	S-006	Abbott	26-Aug-1999
BRETYLIUM	Bretylium tosylate injection in glass	19-030	S-009,S-011	Abbott	26-Aug-1999
ORTHO-NOVUM 1/35-21	Ethinyl estradiol/norethindrone tablets	17-489	S-084	Johnson RW	27-Aug-1999
ORTHO-NOVUM 10/11-21	Ethinyl estradiol/norethindrone tablets	18-354	S-034,037	Johnson RW	27-Aug-1999
ORTHO-NOVUM 7/7/7-21	Ethinyl estradiol/norethindrone tablets	18-985	S-030,033	Johnson RW	27-Aug-1999
ZOFRAN	Ondansetron HCl tablets	20-103	S-015	Glaxo Wellcome	27-Aug-1999
XENICAL	Orlistat capsules	20-766	S-001	Roche	31-Aug-1999

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Date created: April 20, 2000; last update: July 7, 2005