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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079245

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NDA 079245 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 six 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. Six suppliers are listed for this compound. Additional details are available on the fosinopril sodium; hydrochlorothiazide profile page.
Summary for 079245
Tradename:FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Applicant:Aurobindo Pharma
Ingredient:fosinopril sodium; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079245
Ingredient-typeThiazides
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 Citron Pharma LLC 57237-026 N 57237-026-30
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium; hydrochlorothiazide TABLET;ORAL 079245 ANDA Citron Pharma LLC 57237-026 N 57237-026-01

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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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
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Cerilliant
Citi
Johnson and Johnson
Accenture
McKinsey
Medtronic

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