Source facts
FDA issued a tentative approval letter for GLYCEROL PHENYLBUTYRATE on 2026-02-11. The source metadata identifies ANDA 220313 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordTA · Tentative Approval Letter
GLYCEROL PHENYLBUTYRATE — FDA Tentative Approval Letter (ANDA 220313)
Issued to AUROBINDO PHARMA. Application meets requirements but marketing is blocked (patent/exclusivity).
Issued
February 11, 2026Application
ANDA 505j • 220313
Product
GLYCEROL PHENYLBUTYRATE
Company
AUROBINDO PHARMA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for GLYCEROL PHENYLBUTYRATE?
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Key details in this letter
- 1FDA action: tentative approval.
- 2Application: ANDA 220313.
- 3Submission: original application.
- 4Sponsor: AUROBINDO PHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the GLYCEROL PHENYLBUTYRATE tentative approval letter
Is GLYCEROL PHENYLBUTYRATE FDA approved?
Not for marketing yet. FDA granted tentative approval to ANDA 220313 for GLYCEROL PHENYLBUTYRATE on February 11, 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 220313?
ANDA 220313 is the application under which FDA issued this tentative approval letter for GLYCEROL PHENYLBUTYRATE to AUROBINDO PHARMA. The letter is dated February 11, 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.