Source facts
FDA issued an approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211583 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE — FDA Approval Letter (ANDA 211583)
Issued to TEVA PHARMS USA INC. Application is approved as submitted.
Issued
June 9, 2026Application
ANDA 505j • 211583
Product
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Company
TEVA PHARMS USA INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 211583.
- 3Submission: original application.
- 4Sponsor: TEVA PHARMS USA INC.
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 METFORMIN HYDROCHLORIDE approval letter
Is DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 211583 for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, sponsored by TEVA PHARMS USA INC, 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 211583?
ANDA 211583 is the application under which FDA issued this approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE to TEVA PHARMS USA INC. 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.