Source facts
FDA issued a tentative approval letter for GABAPENTIN ENACARBIL on 2026-06-08. The source metadata identifies ANDA 220420 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
GABAPENTIN ENACARBIL — FDA Tentative Approval Letter (ANDA 220420)
Issued to ANNORA PHARMA PRIVATE LIMITED. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
June 8, 2026Application
ANDA 505j • 220420
Product
GABAPENTIN ENACARBIL
Company
ANNORA PHARMA PRIVATE LIMITED
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for GABAPENTIN ENACARBIL?
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Key details in this letter
- 1FDA action: tentative approval.
- 2Application: ANDA 220420.
- 3Submission: original application.
- 4Sponsor: ANNORA PHARMA PRIVATE LIMITED.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the GABAPENTIN ENACARBIL tentative approval letter
Is GABAPENTIN ENACARBIL FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 220420 for GABAPENTIN ENACARBIL on June 8, 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 220420?
ANDA 220420 is the application under which FDA issued this tentative approval letter for GABAPENTIN ENACARBIL to ANNORA PHARMA PRIVATE LIMITED. The letter is dated June 8, 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.