Last Updated: June 24, 2026

Details for New Drug Application (NDA): 211595

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NDA 211595 describes DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Cipla, Cipla Ltd, Lupin, Macleods Pharms Ltd, Micro Labs, MSN, Sun Pharm, and Teva Pharms Usa Inc, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.

Summary for 211595

Tradename:	DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Applicant:	Cipla
Ingredient:	dapagliflozin; metformin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG;1GM
Approval Date:	Apr 6, 2026	TE:	AB	RLD:	No

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