Epinastine Hydrochloride

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Oct 16, 2003	ElestatNDA 21565 · New molecular entity	Allergan	4	Discontinued
Mar 14, 2011	Epinastine HydrochlorideANDA 90870	Pharmobedient	1	Discontinued
Oct 31, 2011	Epinastine HydrochlorideANDA 90919	Apotex	1	Discontinued
Oct 31, 2011	Epinastine HydrochlorideANDA 90951	Somerset Theraps LLC	1	Marketed
Oct 31, 2011	Epinastine HydrochlorideANDA 91626	Sun Pharm Inds	1	Discontinued
Dec 7, 2016	Epinastine HydrochlorideANDA 203384	Chartwell Rx	0	Discontinued
May 5, 2017	Epinastine HydrochlorideANDA 204055	Epic Pharma LLC	0	Discontinued
—	Epinastine HydrochlorideANDA 90950	Sandoz	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