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Details for New Drug Application (NDA): 090416

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NDA 090416 describes MOEXIPRIL HYDROCHLORIDE, which is a drug marketed by Teva, Glenmark Generics, Paddock Llc, Apotex Inc, Glenmark Pharms, and Heritage Pharms Inc, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the MOEXIPRIL HYDROCHLORIDE profile page.

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

Summary for NDA: 090416

Tradename:
MOEXIPRIL HYDROCHLORIDE
Applicant:
Glenmark Generics
Ingredient:
moexipril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090416

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 30, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Mar 30, 2010TE:ABRLD:No


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