Source facts
FDA issued an approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211533 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE — FDA Approval Letter (ANDA 211533)
Issued to MSN. Application is approved as submitted.
Issued
June 9, 2026Application
ANDA 505j • 211533
Product
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE
Company
MSN
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 211533.
- 3Submission: original application.
- 4Sponsor: MSN.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE approval letter
Is DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 211533 for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE, sponsored by MSN, 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 211533?
ANDA 211533 is the application under which FDA issued this approval letter for DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE to MSN. 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.