Captopril

Sold as Capoten. Every FDA application for this active ingredient: 1 branded and 26 generic.

As of Nov 13, 2026, FDA lists 27 applications for Captopril (sold as Capoten), first approved Apr 6, 1981, with 6 new uses approved and 0 published complete response letters.

First approved: Apr 6, 1981
Applications: 27
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $4.0M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Captopril	Part D	$4.0M	-22%	15,731

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Apr 6, 1981	CapotenNDA 18343 · New molecular entity	Aarxion Anda Hlding	77	Discontinued
Mar 31, 1995	CaptoprilANDA 74472	Apothecon	2	Discontinued
Nov 9, 1995	CaptoprilANDA 74363	Chartwell Rx	12	Discontinued
Feb 13, 1996	CaptoprilANDA 74322	Teva	10	Discontinued
Feb 13, 1996	CaptoprilANDA 74418	Tp Anda Holdings	5	Discontinued
Feb 13, 1996	CaptoprilANDA 74423	Dava Pharms Inc	2	Discontinued
Feb 13, 1996	CaptoprilANDA 74433	Cosette Pharms Nc	0	Discontinued
Feb 13, 1996	CaptoprilANDA 74434	Aurobindo Pharma USA	11	Discontinued
Feb 13, 1996	CaptoprilANDA 74451	Watson Labs	3	Discontinued
Feb 13, 1996	CaptoprilANDA 74462	Cosette Pharms Nc	4	Discontinued
Feb 13, 1996	CaptoprilANDA 74477	Prinston Inc	2	Marketed
Feb 13, 1996	CaptoprilANDA 74481	Sandoz	4	Discontinued
Feb 13, 1996	CaptoprilANDA 74483	Cosette Pharms Nc	14	Discontinued
Feb 13, 1996	CaptoprilANDA 74493	Strides Pharma Intl	4	Discontinued
Feb 13, 1996	CaptoprilANDA 74505	Hikma	18	Marketed
Feb 13, 1996	CaptoprilANDA 74519	Chartwell Rx	1	Discontinued
Apr 23, 1996	CaptoprilANDA 74576	Watson Labs	5	Discontinued
May 23, 1996	CaptoprilANDA 74386	Watson Labs	7	Discontinued
Aug 30, 1996	CaptoprilANDA 74590	G And W Labs Inc	1	Discontinued
Mar 28, 1997	CaptoprilANDA 74532	Wockhardt Bio AG	7	Marketed
May 29, 1997	CaptoprilANDA 74748	Egis Pharms	1	Discontinued
May 30, 1997	CaptoprilANDA 74677	Andas 5 Holding	0	Marketed
Oct 28, 1998	CaptoprilANDA 74737	Macleods Pharms	7	Marketed
Oct 30, 2019	CaptoprilANDA 212223	Seton Pharms	0	Discontinued
Dec 13, 2019	CaptoprilANDA 212809	Ajanta Pharma Ltd	0	Marketed
Jan 27, 2023	CaptoprilANDA 214442	Aiping Pharm Inc	0	Marketed
—	CaptoprilANDA 74640	Purepac Pharm	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. Drugs@FDA