Last Updated: September 24, 2026

Details for New Drug Application (NDA): 211583


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NDA 211583 describes DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma, Cipla, Cipla Ltd, Lupin, Macleods Pharms, 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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.
Summary for 211583
Tradename:DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Applicant:Teva Pharms Usa Inc
Ingredient:dapagliflozin; metformin hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG;1GM
Approval Date:Apr 6, 2026TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;500MG
Approval Date:Apr 6, 2026TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;1GM
Approval Date:Apr 6, 2026TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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