Clemastine Fumarate

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Feb 25, 1977	Tavist, Tavist-1NDA 17661 · New molecular entity	Novartis	43	Discontinued
Jun 28, 1985	TavistNDA 18675 · New dosage form	Novartis	6	Discontinued
Jan 31, 1992	Clemastine FumarateANDA 73282	Ani Pharms	30	Discontinued
Jan 31, 1992	Clemastine FumarateANDA 73283	Genus	28	Marketed
Apr 21, 1992	Clemastine FumarateANDA 73095	Teva Pharms	9	Discontinued
Aug 21, 1992	Tavist-1NDA 20925 · TYPE 8	Haleon US Holdings	2	Discontinued
Oct 31, 1993	Clemastine FumarateANDA 73458	Pld Acquisitions LLC	10	Discontinued
Oct 31, 1993	Clemastine FumarateANDA 73459	Omnivium Pharms	10	Discontinued
Oct 31, 1993	Clemastine FumarateANDA 74075	Actavis Mid Atlantic	6	Discontinued
Jun 30, 1994	Clemastine FumarateANDA 73399	Genus	17	Marketed
Nov 22, 1995	Clemastine FumarateANDA 74512	L Perrigo Co	8	Discontinued
Dec 17, 1997	Clemastine FumarateANDA 74884	Genus Lifesciences	2	Marketed
Mar 13, 1998	Clemastine FumarateANDA 74863	Wockhardt Bio AG	1	Discontinued
Nov 27, 2000	Clemastine FumarateANDA 75703	Apotex Inc	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA