Reference Listed Drug Labeling Approved in February 2000

Reference Listed Drug Labeling Approved in February 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	FEB
LEVAQUIN	Levofloxacin inj	20-635/S-008	Johnson RW	2
LEVAQUIN	Levofloxacin tabs	20-634/S-009	Johnson RW	2
SCLEROSOL	Sterile talc powder	20-587/S-001	Bryan	2
TRIPHASIL-21	Levonorgestrel/ethinyl estradiol tab	19-192/S-033	Wyeth Ayerst	2
UNIVASC	Moexipril HCl tab	20-312/S-014	SPKU	2
E.E.S.	Erythromycin ethylsuccinate tab	50-297/S-018	Abbott	4
ERYPED	Erythromycin ethylsuccinate oral susp	50-207/S-054	Abbott	4
NOVANTRONE	Mitoxantrone hydrochloride inj	19-297/S-021	Immunex	4
PCE	Erythromycin tab	50-611/S-018	Abbott	4
ACCOLATE	Zafirlukast tab	20-547/S-011	Zeneca	7
ZESTRIL	Lisinopril tab	19-777/S-037	Zeneca Pharms	7
GASTROCROM	Cromolyn Na⁺ oral sol	20-479/S-002	Medeva Pharms	8
PLENDIL	Felodipine tab	19-834/S-014	Astrazeneca	8
SYPRINE	Trientine hydrochloride cap	19-194/S-005	Merck	8
ACTIVELLE	Estradiol/norethindronate acetate aer	20-907/S-002	Novo Nordisk	10
PRAVACHOL	Pravastatin sodium tab	19-898/S-032	Bristol Myers Squibb	10
CERVIDIL	Dinoprostone vaginal tab	20-411/S-014	Contrlld Therap	11
K⁺ ACETATE	Potassium acetate inj	18-896/S-008	Abbott	11
THAM	Tromethamine inj	13-025/S-037	Abbott	11
MEFOXIN	Cefoxitin sodium inj	50-517/S-038	Merck	14
VESANOID	Tretinoin cap	20-438/S-001	Roche	14
MIRCETTE	Desogestrel/ethinyl estradiol tab	20-713/S-004	Organon	15
TRUSOPT	Dorzolamide hydrochloride opth sol	20-408/S-019	Merck	15
NICODERM CQ	Nicotine transdermal system	20-165/S-016	Hoechst Marion	16
COUMADIN	Warfarin sodium tab	9-218/S-097	Dupont Merck	17
INAPSINE	Droperidol inj	16-796/S-035	Akorn	18
PLAVIX	Clopidogrel bisulfate tab	20-839/S-006	Sanofi Synthela	22
ARAVA	Leflunomide tab	20-905/S-004	Hoechst Marion	23
ISUPREL	Isoproterenol HCl inj	10-515/S-023	Abbott	23
PRILOSEC	Omeprazole cap	19-810/S-062	Astrazeneca	23
NIMBEX	Nimbex inj	20-551/S-007	Abbott	25
PERIACTIN	Cyproheptadine HCl tab	12-649/S-047	Merck	25
SEREVENT	Salmeterol xinafoate	20-236/S-018	Glaxo Wellcome	25
ZYRTEC	Cetirizine HCl oral sol	20-346/S-006	Pfizer	25
ZYRTEC	Cetirizine HCl tab	19-835/S-010	Pfizer	25
ARICEPT	Donepezil HCl tab	20-690/S-008	Eisai (Us)	28
REMERON	Mirtazapine tab	20-415/S-007	Organon	28

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