Issued to ALKEM LABS LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
June 9, 2026Application
ANDA 505j • 211563
Product
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Company
ALKEM LABS LTD
Stage
Final Decision
Assyro regulatory brief
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FDA issued a tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on 2026-06-09. The source metadata identifies ANDA 211563 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
Not for marketing yet. FDA granted tentative approval to ANDA 211563 for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE on June 9, 2026, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
ANDA 211563 is the application under which FDA issued this tentative approval letter for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE to ALKEM LABS LTD. The letter is dated June 9, 2026.
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.