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Generated: February 21, 2018

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 Actavis Labs Fl Inc, Aurobindo Pharma, Emcure Pharms Ltd, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, 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 079025
Tradename:FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Applicant:Emcure Pharms Ltd
Ingredient:fosinopril sodium; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079025
Ingredient-typeThiazides
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. 23155-060 N 23155-060-01
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079025 ANDA Heritage Pharmaceuticals Inc. 23155-060 N 23155-060-05

Profile for product number 001

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

Profile for product number 002

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

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