Sulfamethoxazole

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jul 1, 1965	GantanolNDA 13664 · New formulation or manufacturer	Roche	3	Discontinued
Aug 25, 1965	Gantanol, Gantanol-DsNDA 12715 · New molecular entity	Roche	6	Discontinued
Mar 23, 1978	SulfamethoxazoleANDA 85844	Rising	12	Discontinued
Jul 25, 1983	SulfamethoxazoleANDA 87189	Barr	0	Discontinued
—	SulfamethoxazoleANDA 85053	Watson Labs	0	Discontinued
—	SulfamethoxazoleANDA 86000	Watson Labs	0	Discontinued
—	SulfamethoxazoleANDA 86163	Heather	0	Discontinued
—	UrobakANDA 87307	Shionogi	0	Discontinued
—	SulfamethoxazoleANDA 87662	Ascot	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