Issued to INVENTIA. Application is approved as submitted.
Posted by FDA
June 9, 2026Application
ANDA 505j • 211156
Product
DAPAGLIFLOZIN
Company
INVENTIA
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for DAPAGLIFLOZIN on 2026-06-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved ANDA 211156 for DAPAGLIFLOZIN, sponsored by INVENTIA,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 211156 is the application under which FDA issued this approval letter for DAPAGLIFLOZIN to INVENTIA. FDA posted the letter on June 9, 2026; the posting date is not the decision date.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.