Source facts
FDA issued a tentative approval letter for SITAGLIPTIN PHOSPHATE on 2026-06-02. The source metadata identifies ANDA 215155 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
SITAGLIPTIN PHOSPHATE — FDA Tentative Approval Letter (ANDA 215155)
Issued to ALKEM LABS LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
June 2, 2026Application
ANDA 505j • 215155
Product
SITAGLIPTIN PHOSPHATE
Company
ALKEM LABS LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for SITAGLIPTIN PHOSPHATE?
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Key details in this letter
- 1FDA action: tentative approval.
- 2Application: ANDA 215155.
- 3Submission: original application.
- 4Sponsor: ALKEM LABS LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the SITAGLIPTIN PHOSPHATE tentative approval letter
Is SITAGLIPTIN PHOSPHATE FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 215155 for SITAGLIPTIN PHOSPHATE on June 2, 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.
What is ANDA 215155?
ANDA 215155 is the application under which FDA issued this tentative approval letter for SITAGLIPTIN PHOSPHATE to ALKEM LABS LTD. The letter is dated June 2, 2026.
What happens after an FDA tentative approval letter?
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.