Candesartan Cilexetil

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jun 4, 1998	AtacandNDA 20838 · New molecular entity	Ani Pharms	29	Marketed
May 3, 2013	Candesartan CilexetilANDA 78702	Mylan	3	Marketed
Jan 10, 2014	Candesartan CilexetilANDA 202079	Apotex	1	Discontinued
Dec 5, 2016	Candesartan CilexetilANDA 203813	Macleods Pharms	3	Marketed
Jun 20, 2017	Candesartan CilexetilANDA 209119	Alembic	1	Marketed
Aug 23, 2017	Candesartan CilexetilANDA 91390	Zydus Lifesciences	1	Marketed
Dec 4, 2018	Candesartan CilexetilANDA 210302	Alembic	1	Marketed
Aug 21, 2023	Candesartan CilexetilANDA 206233	Prinston	0	Marketed

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