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US FDA source recordAL · Approval Letter

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER — FDA Approval Letter (NDA 050639)

Issued to PFIZER. Application is approved as submitted.

Issued

March 30, 2026

Application

NDA 505b1 • 050639

Product

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Company

PFIZER

Stage

Final Decision

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What did FDA decide for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER?

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Source facts

FDA issued an approval letter for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER on 2026-03-30. The source metadata identifies NDA 050639 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 050639.
  • 3Submission: supplement.
  • 4Sponsor: PFIZER.

Suggested next step

Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER approval letter

Is CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER FDA approved?

This letter documents an FDA approval action: FDA approved NDA 050639 for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, 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 050639?

NDA 050639 is the application under which FDA issued this approval letter for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER 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.