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Generated: September 19, 2018

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Details for New Drug Application (NDA): 076980

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NDA 076980 describes MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Chartwell Rx, Glenmark Pharms, Heritage Pharms Inc, and Teva, and is included in four NDAs. It is available from four suppliers. Additional details are available on the MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; moexipril hydrochloride. There are thirty-two 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 076980
Pharmacology for NDA: 076980
Ingredient-typeThiazides
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 076980
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 076980 ANDA Teva Pharmaceuticals USA, Inc. 0093-5213 0093-5213-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5213-01)
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 076980 ANDA Teva Pharmaceuticals USA, Inc. 0093-5214 0093-5214-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5214-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;7.5MG
Approval Date:Mar 7, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;15MG
Approval Date:Mar 7, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;15MG
Approval Date:Mar 7, 2007TE:ABRLD:No

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