Source facts
FDA issued an approval letter for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER on 2026-06-11. The source metadata identifies NDA 206473 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER — FDA Approval Letter (NDA 206473)
Issued to HOSPIRA. Application is approved as submitted.
Issued
June 11, 2026Application
NDA 505b1 • 206473
Product
LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Company
HOSPIRA
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 206473.
- 3Submission: supplement.
- 4Sponsor: HOSPIRA.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER approval letter
Is LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 206473 for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, sponsored by HOSPIRA, on June 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 206473?
NDA 206473 is the application under which FDA issued this approval letter for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER to HOSPIRA. The letter is dated June 11, 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.