Details for New Drug Application (NDA): 090416

NDA 090416 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 two suppliers. Additional details are available on the MOEXIPRIL HYDROCHLORIDE profile page.

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

Summary for 090416

Tradename:	MOEXIPRIL HYDROCHLORIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	moexipril hydrochloride
Patents:	0

Pharmacology for NDA: 090416

Mechanism of Action

Angiotensin-converting Enzyme Inhibitors

Suppliers and Packaging for NDA: 090416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOEXIPRIL HYDROCHLORIDE	moexipril hydrochloride	TABLET;ORAL	090416	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-208	68462-208-01	100 TABLET, FILM COATED in 1 BOTTLE (68462-208-01)
MOEXIPRIL HYDROCHLORIDE	moexipril hydrochloride	TABLET;ORAL	090416	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-208	68462-208-10	1000 TABLET, FILM COATED in 1 BOTTLE (68462-208-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Mar 30, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Mar 30, 2010	TE:	AB	RLD:	No

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