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US FDA source recordAL · Approval Letter

CEFEPIME IN PLASTIC CONTAINER — FDA Approval Letter (NDA 050817)

Issued to BAXTER HLTHCARE. Application is approved as submitted.

Issued

June 29, 2026

Application

NDA 505b1 • 050817

Product

CEFEPIME IN PLASTIC CONTAINER

Company

BAXTER HLTHCARE

Stage

Final Decision

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What did FDA decide for CEFEPIME IN PLASTIC CONTAINER?

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Source facts

FDA issued an approval letter for CEFEPIME IN PLASTIC CONTAINER on 2026-06-29. The source metadata identifies NDA 050817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 050817.
  • 3Submission: supplement.
  • 4Sponsor: BAXTER HLTHCARE.

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 CEFEPIME IN PLASTIC CONTAINER approval letter

Is CEFEPIME IN PLASTIC CONTAINER FDA approved?

This letter documents an FDA approval action: FDA approved NDA 050817 for CEFEPIME IN PLASTIC CONTAINER, sponsored by BAXTER HLTHCARE, on June 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 050817?

NDA 050817 is the application under which FDA issued this approval letter for CEFEPIME IN PLASTIC CONTAINER to BAXTER HLTHCARE. The letter is dated June 29, 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.