Trimethoprim

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
May 30, 1980	ProloprimNDA 17943 · New dosage form	Monarch Pharms	16	Discontinued
May 30, 1980	Trimpex, Trimpex 200NDA 17952 · New formulation or manufacturer	Roche	12	Discontinued
Jul 30, 1982	TrimethoprimNDA 18679	Dr Reddys Labs SA	30	Marketed
Jun 6, 1985	TrimethoprimANDA 70049	Watson Labs	11	Marketed
Jan 23, 1986	TrimethoprimANDA 70494	Sun Pharm Industries	10	Discontinued
Mar 14, 1986	TrimethoprimANDA 70495	Sun Pharm Industries	10	Discontinued
Jun 18, 1987	TrimethoprimANDA 71259	Teva	16	Discontinued
Jun 15, 2011	TrimethoprimANDA 91437	Novel Labs Inc	2	Marketed
Oct 28, 2022	TrimethoprimANDA 216393	Novitium Pharma	0	Marketed
Oct 23, 2026	TrimethoprimANDA 221194	Bionpharma	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