Last Updated: May 3, 2026

Details for New Drug Application (NDA): 211523


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NDA 211523 describes DAPAGLIFLOZIN, which is a drug marketed by Aizant, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Biocon Pharma, Cipla, Inventia, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, MSN, Sandoz, Teva Pharms Usa, Zydus Pharms, Cipla Ltd, Sun Pharm, Teva Pharms Usa Inc, and Torrent, and is included in twenty-seven NDAs. It is available from sixteen suppliers. Additional details are available on the DAPAGLIFLOZIN profile page.

The generic ingredient in DAPAGLIFLOZIN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.
Summary for 211523
Tradename:DAPAGLIFLOZIN
Applicant:Aizant
Ingredient:dapagliflozin
Patents:0
Pharmacology for NDA: 211523
Mechanism of ActionSodium-Glucose Transporter 2 Inhibitors
Suppliers and Packaging for NDA: 211523
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAPAGLIFLOZIN dapagliflozin TABLET;ORAL 211523 ANDA Apotex Corp. 60505-4911 60505-4911-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-4911-3)
DAPAGLIFLOZIN dapagliflozin TABLET;ORAL 211523 ANDA Apotex Corp. 60505-4912 60505-4912-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60505-4912-3)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
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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