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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074386

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NDA 074386 describes CAPTOPRIL, which is a drug marketed by Aiping Pharm Inc, Ajanta Pharma Ltd, Andas 5 Holding, Apothecon, Aurobindo Pharma Usa, Chartwell Rx, Corepharma, Cosette, Dava Pharms Inc, Egis Pharms, G And W Labs Inc, Hikma Intl Pharms, Oxford Pharms, Prinston Inc, Purepac Pharm, Sandoz, Seton Pharms, Strides Pharma Intl, Teva, Watson Labs, Wockhardt Bio Ag, Ivax Sub Teva Pharms, and Rising, and is included in thirty-one NDAs. It is available from thirteen suppliers. Additional details are available on the CAPTOPRIL profile page.

The generic ingredient in CAPTOPRIL is captopril; hydrochlorothiazide. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the captopril; hydrochlorothiazide profile page.

Summary for 074386

Tradename:	CAPTOPRIL
Applicant:	Watson Labs
Ingredient:	captopril
Patents:	0

Medical Subject Heading (MeSH) Categories for 074386

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	May 23, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	May 23, 1996	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	May 23, 1996	TE:		RLD:	No

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