Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078454

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NDA 078454 describes MOEXIPRIL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Chartwell Rx, Glenmark Pharms Ltd, Teva, Glenmark Pharms, and Heritage, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the MOEXIPRIL HYDROCHLORIDE profile page.

The generic ingredient in MOEXIPRIL HYDROCHLORIDE is hydrochlorothiazide; moexipril hydrochloride. There are two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; moexipril hydrochloride profile page.

Summary for 078454

Tradename:	MOEXIPRIL HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	moexipril hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Jun 2, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 2, 2008	TE:		RLD:	No

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