Details for New Drug Application (NDA): 076265

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NDA 076265 describes LISINOPRIL AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Aurobindo, Chartwell Rx, Corepharma, Epic Pharma Llc, Hikma Intl Pharms, Invagen Pharms, Lupin, Norvium Bioscience, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from thirty-one suppliers. Additional details are available on the LISINOPRIL AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in LISINOPRIL AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; lisinopril. There are thirty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; lisinopril profile page.

Tradename:	LISINOPRIL AND HYDROCHLOROTHIAZIDE
Applicant:	Hikma Intl Pharms
Ingredient:	hydrochlorothiazide; lisinopril
Patents:	0

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Increased Diuresis

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076265	ANDA	Aphena Pharma Solutions - Tennessee, LLC	43353-975	43353-975-30	30 TABLET in 1 BOTTLE, PLASTIC (43353-975-30)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;10MG
Approval Date:	Jul 8, 2002	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG;20MG
Approval Date:	Jul 8, 2002	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;20MG
Approval Date:	Jul 8, 2002	TE:		RLD:	No

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