CMS TransmittalInfectious Disease

FDA Approval: CEFEPIME (CEFEPIME) — Type 3 - New Dosage Form

FDA-NDA050817

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-NDA050817
Published
July 1, 2026
Effective date
August 5, 2008
MAC region
National

Summary

Baxter Healthcare's new dosage form of cefepime (injectable, NDA050817) follows the Part B billing pathway, consistent with its intravenous/injection route of administration typically administered in

Cefepime injectable (new dosage form) bills under Part B.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050817s000ltr.pdf

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