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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 Glenmark Pharms, Teva, and Paddock Llc, and is included in three NDAs. It is available from two 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-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: 076980

hydrochlorothiazide; moexipril hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 076980

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
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)
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)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;15MG
Approval Date:Mar 7, 2007TE:ABRLD:Yes

Summary for product number 003

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

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