Phenylbutazone

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Oct 29, 1979	PhenylbutazoneANDA 86151	Watson Labs	4	Discontinued
Jan 10, 1980	PhenylbutazoneANDA 84339	Fosun Pharma	11	Discontinued
Oct 13, 1981	AzolidANDA 87260	Sanofi Aventis US	0	Discontinued
Apr 21, 1982	PhenylbutazoneANDA 87674	Watson Labs	0	Discontinued
Jun 16, 1982	PhenylbutazoneANDA 87774	Chartwell Rx	2	Discontinued
Dec 17, 1982	PhenylbutazoneANDA 87756	Watson Labs	4	Discontinued
Jun 24, 1983	PhenylbutazoneANDA 88218	Ivax Pharms	0	Discontinued
Dec 4, 1985	PhenylbutazoneANDA 88863	Sun Pharm Industries	12	Discontinued
Dec 4, 1985	PhenylbutazoneANDA 88994	Sun Pharm Industries	11	Discontinued
Jun 25, 1997	ButazolidinNDA 8319 · New molecular entity, new combination	Novartis	18	Discontinued
—	AzolidANDA 87091	Sanofi Aventis US	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