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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079025


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NDA 079025 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 079025
Pharmacology for NDA: 079025
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 079025
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079025 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-060 23155-060-01 100 TABLET in 1 BOTTLE (23155-060-01)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079025 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-060 23155-060-03 30 TABLET in 1 BOTTLE (23155-060-03)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Sep 17, 2010TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Sep 17, 2010TE:RLD:No

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