Reference Listed Drug Labeling Approved in April 2000

Reference Listed Drug Labeling Approved in April 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 Ingredient(s) / Dosage Form		NDA/Sup#		Firm	April
AMICAR	Aminocaproic acid	INJ	15-229	030	Immunex	3
AMICAR	Aminocaproic acid	TAB	15-197	034	Immunex	3
LO/OVRAL	Norgestrel/ethinyl estradiol	TAB	17-612	031	Wyeth Ayerst	3
NORDETTE-21	Levonorgestrel/ethinyl estradiol	TAB	18-668	030	Wyeth Ayerst	3
PREVEN	Levonorgestrel/ ethinyl estradiol	TAB	20-946	005	Gynetics	3
CALCIJEX	Calcitriol	INJ	18-874	010	Abbott	4
SEROSTIM	Somatropin	INJ	20-604	006	Serono	4
TENORETIC	Atenolol/chlorthalidone	TAB	18-760	022	Astrazeneca	4
TENORMIN	Atenolol	INJ	19-058	012	Astrazeneca	4
TENORMIN	Atenolol	TAB	18-240	025	Astrazeneca	4
ZEBETA	Bisoprolol fumarate	TAB	19-982	007	Lederle	4
ZIAC	Bisoprolol fumarate/HCTZ	TAB	20-186	011	Lederle	4
ELAVIL	Amitriptyline HCl	INJ	12-704	044	Astrazeneca	5
ELAVIL	Amitriptyline HCl	TAB	12-703	090	Astrazeneca	5
MAVIK	Trandolapril	TAB	20-528	004	Knoll Pharm	5
TIAZAC	Diltiazem HCl	EXC	20-401	015	Biovail	5
UNIRETIC	Moexipril HCl/HCTZ	TAB	20-729	005	Schwarz	5
ASENDIN	Amoxapine	TAB	18-021	037	Lederle	6
PEPCID AC	Famotidine	TAB	20-801	002	Merck	6
XENICAL	Orlistat/tetrahydrolipstatin	CAP	20-766	004	Roche	6
KEPPRA	Levetiracetam	TAB	21-035	003	UCB	10
RILUTEK	Riluzole	TAB	20-599	006	Aventis	10
SINEQUAN	Doxepin HCl	CAP	16-798	048	Pfizer	10
SINEQUAN ORAL CONCENTRATE	Doxepin HCl	SOL	17-516	018	Pfizer	10
TEGRETOL CHEWABLE TABLETS	Carbamazepine	TAB	18-281	037	Novartis	10
TEGRETOL ORAL SUSPENSION	Carbamazepine	SUS	18-927	028	Novartis	10
TEGRETO L	Carbamazepine	TAB	16-608	088	Novartis	10
TEGRETOL-XR	Carbamazepine	EXT	20-234	014	Novartis	10
WELLBUTRIN	Bupropion HCl	TAB	18-644	021	Glaxo Wellcome	10
WELLBUTRIN SR	Bupropion HCl	EXT	20-358	016	Glaxo Wellcome	10
ACTIVELLE	Estradiol/norethindronate acetate	TAB	20-907	003	Novo Nordisk	11
CRIXIVAN	Indinavir sulfate	CAP	20-685	035	Merck	11
RESTORIL	Temazepam	CAP	18-163	048	Novartis	11
VIVACTIL	Protriptyline HCl	CAP	16-012	052	Merck	11
ZOFRAN	Ondansetron HCl dihydrate	INJ	20-403	009	Glaxo Wellcome	11
ZOFRAN	Ondansetron HCl	SOL	20-605	004	Glaxo Wellcome	11
ZOFRAN	Ondansetron HCl	TAB	20-103	017	Glaxo Wellcome	11
ZOFRAN	Ondansetron HCl	INJ	20-007	030	Glaxo Wellcome	11
ZOFRAN ODT	Ondansetron	TAB	20-781	001	Glaxo Wellcome	11
AYGESTIN	Norethindrone acetate	TAB	18-405	016	Wyeth Ayerst	12
RIFADIN	Rifampin	CAP	50-420	071	Aventis	12
RIFADIN	Rifampin	INJ	50-627	007	Aventis	12
RIFATER	Isoniazid/pyrazinamide/rifampin	TAB	50-705	003	Aventis	12
CERVIDIL	Dinoprostone	SUP	20-411	016	Contrlld Therap	13
DITROPAN XL	Oxybutynin chloride	EXT	20-897	008	Alza	17
DOSTINEX	Cabergoline	TAB	20-664	004	Pharmacia&Upjohn	17
WYDASE	Hyaluronidase	INJ	6-343	011	Wyeth Ayerst	17
AZULFIDINE	Sulfasalazine	TAB	7-073	113	Pharmacia&Upjohn	18
HIVID	Zalcitabine	TAB	20-199	012	Roche	19
EMLA CREAM	Lidocaine/prilocaine	CRM	19-941	012	Astrazeneca	20
EMLA ANESTHETIC DISC	Lidocaine /prilocaine	TDS	20-962	001	Astrazeneca	20
FEMHRT	Ethinyl estradiol/norethindrone Acetate	TAB	21-065	003	Parke Davis	20
ZIAGEN	Abacavir sulfate	SOL	20-978	001	Glaxo Wellcome	20
ZIAGEN	Abacavir sulfate	TAB	20-977	001	Glaxo Wellcome	20
AGENERASE	Amprenavir	CAP	21-007	003	Glaxo Wellcome	24
AGENERASE	Amprenavir	SOL	21-039	003	Glaxo Wellcome	24
AZULFIDINE	Sulfasalazine	TAB	7-073	109	Pharmacia&Upjohn	24
NORMODYNE	Labetalol HCl	INJ	18-686	026	Schering	25
NORMODYNE	Labetalol HCl	TAB	18-687	021	Schering	25
SURMONTIL	Trimipramine maleate	CAP	16-792	019	Wyeth Ayerst	27
AGENERASE	Amprenavir	CAP	21-007	002	Glaxo Wellcome	28
AGENERASE	Amprenavir	SOL	21-039	002	Glaxo Wellcome	28
PLAVIX	Clopidogrel bisulfate	TAB	20-839	008	Sanofi Synthela	28

FDA/Center for Drug Evaluation and Research
Last Updated: October 02, 2001
Originator: OGD
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