Diflunisal

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Apr 19, 1982	DolobidNDA 18445 · New molecular entity	Merck	43	Discontinued
Jul 31, 1992	DiflunisalANDA 73673	Teva	24	Marketed
Jul 31, 1992	DiflunisalANDA 73679	Teva	10	Discontinued
Nov 27, 1992	DiflunisalANDA 73562	Dastech Intl	3	Discontinued
Nov 27, 1992	DiflunisalANDA 73563	Dastech Intl	3	Discontinued
May 7, 1996	DiflunisalANDA 74285	Purepac Pharm	0	Discontinued
Jun 10, 1996	DiflunisalANDA 74604	Ani Pharms	5	Discontinued
Jul 17, 1997	DiflunisalANDA 74400	Watson Labs	3	Discontinued
Mar 8, 2012	DiflunisalANDA 202845	Heritage Pharma	4	Marketed
Jun 16, 2017	DiflunisalANDA 203547	Zydus Pharms	2	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