Source facts
FDA issued an approval letter for DAPAGLIFLOZIN on 2026-06-09. The source metadata identifies ANDA 211156 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DAPAGLIFLOZIN — FDA Approval Letter (ANDA 211156)
Issued to INVENTIA. Application is approved as submitted.
Issued
June 9, 2026Application
ANDA 505j • 211156
Product
DAPAGLIFLOZIN
Company
INVENTIA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DAPAGLIFLOZIN?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 211156.
- 3Submission: original application.
- 4Sponsor: INVENTIA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
Read the full FDA approval letter (PDF)
Loading document viewer…
Common questions about the DAPAGLIFLOZIN approval letter
Is DAPAGLIFLOZIN FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 211156 for DAPAGLIFLOZIN, sponsored by INVENTIA, on June 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 211156?
ANDA 211156 is the application under which FDA issued this approval letter for DAPAGLIFLOZIN to INVENTIA. The letter is dated June 9, 2026.
What happens after an FDA approval letter?
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.