Details for New Drug Application (NDA): 079245

NDA 079245 describes FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Mylan, Sandoz, Sun Pharm Inds Ltd, and Teva, and is included in nine NDAs. It is available from two 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. Two 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

Pharmacology for NDA: 079245

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased 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	Aurobindo Pharma Limited	65862-308	65862-308-01	100 TABLET in 1 BOTTLE (65862-308-01)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE	fosinopril sodium; hydrochlorothiazide	TABLET;ORAL	079245	ANDA	Aurobindo Pharma Limited	65862-308	65862-308-30	30 TABLET in 1 BOTTLE (65862-308-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;12.5MG
Approval Date:	Jul 9, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG;12.5MG
Approval Date:	Jul 9, 2009	TE:	AB	RLD:	No

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