Food and Drug Administration • Center for Drug Evaluation and Research

Office of Generic Drugs

Reference Listed Drug Labeling Approved in March 2000

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.

TRADENAME	ACTIVE/DOSAGE FORM	NDA#	SUPP#	FIRM	MAR
DIOVAN HCT	Valsartan/HCTZ/tab	20-818	S-006	Novartis Pharms	1
TIMOPTIC in OCCUDOSE	Timolol maleate/opth.sol	19-463	S-020	Merck	2
EFFEXOR	Venlafaxine HCl	20-151	S-014	Wyeth Ayerst	3
EFFEXOR XR	Venlafaxine HCl	20-699	S-008	Wyeth Ayerst	3
TECZEM	Diltiazem malate/enalapril maleate	20-507	S-002	Aventis Pharms	3
PROPULSID	Cisapride/oral sol	20-398	S-022	Janssen	6
PROPULSID	Cisapride/tab	20-210	S-032	Janssen	6
ZADITOR	Ketotifen fumarate/ophth sol	21-066	S-001	Ciba Vision	8
MAGNEVIST	Gadopentetate dimeglumine/inj	19-596	S-018	Berlex Labs	10
AGRYLIN	Anagrelide HCl/cap	20-333	S-004	Roberts Labs	13
KETALAR	Ketamine HCl/inj	16-812	S-029	Parkedale	14
NORVASC	Amlodipine besylate/tab	19-787	S-023	Pfizer-Agri	14
OPTISON	Human albumin microspheres/inj	20-899	S-003	Molecular Biosy	14
MUSTARGEN	Mechlorethamine HCl	6-695	S-028	Merck	15
MYLERAN	Busulfan	9-386	S-017	Glaxo Wellcome	15
ZOVIRAX	Acyclovir/tab	20-089	S-012	Glaxo Wellcome	15
ZOVIRAX	Acyclovir/cap	18-828	S-024	Glaxo Wellcome	15
ZOVIRAX	Acyclovir/oral susp.	19-909	S-014	Glaxo Wellcome	15
CLOZARIL	Clozapine/tab	19-758	S-041	Novartis Pharms	17
VIOXX	Rofecoxib/tab	21-042	S-003	Merck Res	17
VIOXX	Rofecoxib/oral sol	21-052	S-003	Merck Res	17
BRETHINE	Terbutaline sulfate/inj	18-571	S-015	Novartis Pharms	21
PANHEPARIN	Heparin Na/inj	5-264	S-073	Abbott Labs	21
TRIPHASIL	Levonorgestrel/ethinyl estradiol/tab	19-192	S-035	Wyeth Ayerst Labs	23
TIAZAC	Diltiazem HCl/extended release caps	20-401	S-019	Biovail Labs	24
XELODA	Capecitabine/tab	20-896	S-007	Hoffman LaRoche	24
PROGESTERONE	Progesterone/inj	17-362	S-089	Steris	27
TOFRANIL-PM	Imipramine pamoate/cap	17-090	S-062	Novartis Pharms	27
VIVACTIL	Protriptyline HCl	16-012	S-046	Merck	27
ZEMURON (P/F)	Rocuronium br/inj	20-214	S-010	Organon	27
LIMBITROL DS	Chlordiazepoxide/amitriptyline HCl	16-949	S-032	ICN Pharms	28
VIRACEPT	Nelfinavir mesylate/inj	20-779	S-029	Agouron	28
VIRACEPT	Nelfinavir mesylate/fij	20-778	S-013	Agouron	28
EPIVIR-HBV	Lamivudine/tab	21-003	S-001	Glaxo Wellcome	31
EPIVIR-HBV	Lamivudine/oral sol	21-004	S-001	Glaxo Wellcome	31
INVERSINE	Mecamylamine/tab	10-251	S-020	Layton	31

FDA/Center for Drug Evaluation and Research
Last Updated:January 18, 2006
Originator: OPS/OGD
HTML by  JFG