Federal Register NoticeInfectious Disease

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

FDA-NDA021132

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA021132
Published
June 13, 2026
Effective date
April 18, 2000
MAC region
National

Summary

Linezolid for suspension is an oral medication that will be billed under Medicare Part D. Since it does not have an injectable form, there will be no assignment of J-codes. Billing teams should monito

New oral drug linezolid approved; watch for Part D billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21130lbl.pdf

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