Source facts
FDA issued an approval letter for REZZAYO on 2026-07-20. The source metadata identifies NDA 217417 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
REZZAYO — FDA Approval Letter (NDA 217417)
Issued to MUNDIPHARMA. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for REZZAYO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 217417.
- 3Submission: supplement.
- 4Sponsor: MUNDIPHARMA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the REZZAYO approval letter
Is REZZAYO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217417 for REZZAYO, sponsored by MUNDIPHARMA, on July 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217417?
NDA 217417 is the application under which FDA issued this approval letter for REZZAYO to MUNDIPHARMA. The letter is dated July 20, 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.