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Generated: May 26, 2017

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Details for New Drug Application (NDA): 079245

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NDA 079245 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Mylan, Actavis Labs Fl Inc, Emcure Pharms India, Invagen Pharms, Sun Pharm Inds Ltd, Watson Labs, Aurobindo Pharma, Teva, and Sandoz, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE is fosinopril sodium; hydrochlorothiazide. There are six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.

Summary for NDA: 079245

Formulation / Manufacturing:see details

Pharmacology for NDA: 079245

Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 079245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fosinopril sodium; hydrochlorothiazide
TABLET;ORAL 079245 ANDA Citron Pharma LLC 57237-026 57237-026-01 100 TABLET in 1 BOTTLE (57237-026-01)
fosinopril sodium; hydrochlorothiazide
TABLET;ORAL 079245 ANDA Citron Pharma LLC 57237-026 57237-026-30 30 TABLET in 1 BOTTLE (57237-026-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Jul 9, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Jul 9, 2009TE:ABRLD:No

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