Source facts
FDA issued an approval letter for TOFACITINIB CITRATE on 2026-06-08. The source metadata identifies ANDA 215356 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TOFACITINIB CITRATE — FDA Approval Letter (ANDA 215356)
Issued to AUROBINDO PHARMA LTD. Application is approved as submitted.
Issued
June 8, 2026Application
ANDA 505j • 215356
Product
TOFACITINIB CITRATE
Company
AUROBINDO PHARMA LTD
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 215356.
- 3Submission: original application.
- 4Sponsor: AUROBINDO PHARMA LTD.
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Common questions about the TOFACITINIB CITRATE approval letter
Is TOFACITINIB CITRATE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 215356 for TOFACITINIB CITRATE, sponsored by AUROBINDO PHARMA LTD, on June 8, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 215356?
ANDA 215356 is the application under which FDA issued this approval letter for TOFACITINIB CITRATE to AUROBINDO PHARMA LTD. The letter is dated June 8, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.