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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Queensland Health
Johnson and Johnson

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090416

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NDA 090416 describes MOEXIPRIL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Chartwell Rx, Glenmark Generics, Teva, 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. Four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; moexipril hydrochloride profile page.
Summary for 090416
Applicant:Glenmark Generics
Ingredient:moexipril hydrochloride
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 N 68462-208-90
MOEXIPRIL HYDROCHLORIDE moexipril hydrochloride TABLET;ORAL 090416 ANDA Glenmark Pharmaceuticals Inc., USA 68462-208 N 68462-208-10

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Johnson and Johnson

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