Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078217

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NDA 078217 describes CARVEDILOL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Glenmark Pharms Ltd, Hikma, Lupin, MLV, Pliva Hrvatska Doo, Regcon Holdings, Rising, Rubicon Research, Sandoz, Sciegen Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Impax Labs Inc, and Sun Pharm Industries, and is included in nineteen NDAs. It is available from thirty-six suppliers. Additional details are available on the CARVEDILOL profile page.

The generic ingredient in CARVEDILOL is carvedilol phosphate. There are two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

Summary for 078217

Tradename:	CARVEDILOL
Applicant:	Lupin
Ingredient:	carvedilol
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3.125MG
Approval Date:	Sep 5, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	6.25MG
Approval Date:	Sep 5, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	12.5MG
Approval Date:	Sep 5, 2007	TE:		RLD:	No

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