Reference Listed Drug Labeling Approved in September 1999

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FDA/Center for Drug Evaluation and Research

Reference Listed Drug Labeling Approved in September 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
DOBUTAMINE	Dobutamine In 5% Dextrose In Plastic	20-201	S-012	Abbott	01-Sep-1999
DEMULEN 1/35-21	Ethinyl Estradiol/Ethynodiol Diacetate Tablets	18-168	S-026	Searle	02-Sep-1999
DEMULEN 1/50-21	Ethynodiol Diacetate/Ethinyl Estradiol Tablets	16-927	S-062	Searle	02-Sep-1999
MIRAPEX	Pramipexole Tablets	20-667	S-007	Pharmacia & Upjohn	03-Sep-1999
COREG	Carvedilol Tablet	20-297	S-004	SKB Pharms	08-Sep-1999
CYKLOKAPRON	Tranexamic Acid Injection	19-281	S-009	Pharmacia & Upjohn	09-Sep-1999
SERZONE	Nefazodone Hydrochloride Tablets	20-152	S-020	Bristol Myers Squibb	09-Sep-1999
PENTASA	Mesalamine Capsules	20-049	S-006	Roberts Labs	10-Sep-1999
CHILDREN'S MOTRIN	Ibuprofen Oral Suspension	20-516	S-004	McNeil	13-Sep-1999
CHILDREN'S MOTRIN	Ibuprofen Oral Suspension	20-603	S-002	McNeil	13-Sep-1999
JUNIOR STRENGTH MOTRIN	Ibuprofen Chewable Tablets	20-601	S-002	McNeil	13-Sep-1999
JUNIOR STRENGTH MOTRIN	Ibuprofen Tablets	20-602	S-003	McNeil	13-Sep-1999
NIASPAN	Niacin Extended-Release Tablets	20-381	S-007	Kos Pharms	13-Sep-1999
PRAVACHOL	Pravastatin Tablets	19-898	S-036	Bristol Myers Squibb	13-Sep-1999
HEPARIN SODIUM	Heparin Sodium Injection	4-570	S-055	Pharmacia & Upjohn	15-Sep-1999
RAXAR	Grepafloxacin HCl Tablets	20-695	S-005	Glaxo Wellcome	15-Sep-1999
ZOCOR	Simvastatin Tablets	19-766	S-035	Merck	15-Sep-1999
ACCOLATE	Zafirlukast Tablets	20-547	S-007	Zeneca	17-Sep-1999
CARDENE	Nicardipine HCl Capsules	19-488	S-008	Syntex Labs	20-Sep-1999
LEVOPHED	Norepinephrine Bitartrate Injection	7-513	S-022	Abbott Labs	20-Sep-1999
TRASYLOL	Aprotinin injection	20-304	S-008	Bayer	21-Sep-1999
AGENERASE	Amprenavir Capsules	21-007	S-001	Glaxo Wellcome	22-Sep-1999
AGENERASE	Amprenavir Oral Solution	21-039	S-001	Glaxo Wellcome	22-Sep-1999
PERIACTIN	Cyproheptadine HCl Tablets	12-649	S-046	Merck	24-Sep-1999
TRUSOPT	Dorzolamide HCl Ophthalmic Solution	20-408	S-017	Merck	27-Sep-1999
LOVENOX	Enoxaparin Sodium Injection	20-164	S-028	Rhone Poulenc Rorer	28-Sep-1999
CARDENE SR	Nicardipine HCl capsules	20-005	S-005	Syntex Labs	29-Sep-1999

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Last update: July 7, 2005