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Last Updated: September 20, 2020

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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 Ani Pharms Inc, Aurobindo Pharma, Emcure Pharms Ltd, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, and Teva, and is included in nine NDAs. It is available from four 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. Four suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 079245
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 AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079245 ANDA Rising Health, LLC 57237-026 57237-026-01 100 TABLET in 1 BOTTLE (57237-026-01)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079245 ANDA Rising Health, LLC 57237-026 57237-026-30 30 TABLET in 1 BOTTLE (57237-026-30)

Profile for product number 001

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

Profile for product number 002

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

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