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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 078493

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NDA 078493 describes TRANDOLAPRIL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Norvium Bioscience, Teva Pharms, Watson Labs, and Glenmark Pharms Ltd, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the TRANDOLAPRIL profile page.

The generic ingredient in TRANDOLAPRIL is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.

Summary for 078493

Tradename:	TRANDOLAPRIL
Applicant:	Dr Reddys Labs Ltd
Ingredient:	trandolapril
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 25, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Aug 25, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Aug 25, 2008	TE:		RLD:	No

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