Issued to PFIZER. Application is approved as submitted.
Issued
February 13, 2026Application
NDA 505b1 • 050441
Product
CLEOCIN PHOSPHATE / CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Company
PFIZER
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for CLEOCIN PHOSPHATE, CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-02-13. The source metadata identifies NDA 050441, NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 050441 for CLEOCIN PHOSPHATE / CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, sponsored by PFIZER, on February 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 050441 is the application under which FDA issued this approval letter for CLEOCIN PHOSPHATE / CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER to PFIZER. The letter is dated February 13, 2026.
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.