Source facts
FDA issued an approval letter for ZITHROMAX on 2026-07-20. The source metadata identifies NDA 050670, NDA 050730 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZITHROMAX — FDA Approval Letter (NDA 050670)
Issued to PFIZER. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for ZITHROMAX?
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: approval.
- 2Applications: NDA 050670, NDA 050730.
- 3Submission: supplement.
- 4Sponsor: PFIZER.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZITHROMAX approval letter
Is ZITHROMAX FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050670 for ZITHROMAX, sponsored by PFIZER, 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 050670?
NDA 050670 is the application under which FDA issued this approval letter for ZITHROMAX to PFIZER. 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.