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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076139

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NDA 076139 describes FOSINOPRIL SODIUM, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Prinston Inc, Ranbaxy Labs Ltd, Teva, Upsher Smith Labs, Watson Labs, Ani Pharms, Aurobindo Pharma, Mylan, Sandoz, and Sun Pharm Inds Ltd, and is included in twenty NDAs. It is available from seven suppliers. Additional details are available on the FOSINOPRIL SODIUM profile page.

The generic ingredient in FOSINOPRIL SODIUM is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for 076139

Tradename:	FOSINOPRIL SODIUM
Applicant:	Teva
Ingredient:	fosinopril sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 076139

Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 25, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 25, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Nov 25, 2003	TE:	AB	RLD:	No

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