Source facts
FDA issued an approval letter for CLEOCIN PHOSPHATE on 2026-03-30. The source metadata identifies NDA 050441 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CLEOCIN PHOSPHATE — FDA Approval Letter (NDA 050441)
Issued to PFIZER. Application is approved as submitted.
Issued
March 30, 2026Application
NDA 505b1 • 050441
Product
CLEOCIN PHOSPHATE
Company
PFIZER
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CLEOCIN PHOSPHATE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 050441.
- 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 CLEOCIN PHOSPHATE approval letter
Is CLEOCIN PHOSPHATE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 050441 for CLEOCIN PHOSPHATE, sponsored by PFIZER, on March 30, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 050441?
NDA 050441 is the application under which FDA issued this approval letter for CLEOCIN PHOSPHATE to PFIZER. The letter is dated March 30, 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.