Source facts
FDA issued a tentative approval letter for UBROGEPANT on 2026-07-22. The source metadata identifies ANDA 218662 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
UBROGEPANT — FDA Tentative Approval Letter (ANDA 218662)
Issued to ZYDUS PHARMACEUTICALS (USA) INC.. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
July 22, 2026Application
ANDA 505j • 218662
Product
UBROGEPANT
Company
ZYDUS PHARMACEUTICALS (USA) INC.
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for UBROGEPANT?
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: tentative approval.
- 2Application: ANDA 218662.
- 3Submission: original application.
- 4Sponsor: ZYDUS PHARMACEUTICALS (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 UBROGEPANT tentative approval letter
Is UBROGEPANT FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 218662 for UBROGEPANT on July 22, 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 218662?
ANDA 218662 is the application under which FDA issued this tentative approval letter for UBROGEPANT to ZYDUS PHARMACEUTICALS (USA) INC.. The letter is dated July 22, 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.