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FDA NDA · NDA206473

LINEZOLID

Sponsor: HOSPIRA

APPLICATION
NDA206473
TYPE
NDA
ORIGINAL APPROVAL
2015-06-18
LATEST ACTION
2026-06-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription
LINEZOLID 600MG/300ML (2MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-09Labeling · Supplement 13 · standard — Letter ↗AP
2025-05-29Labeling · Supplement 11 · standard — Letter ↗AP
2024-11-08Labeling · Supplement 10 · standard — Label ↗AP
2022-02-17Labeling · Supplement 7 · standard — Label ↗AP
2022-01-18Labeling · Supplement 5 · standard — Letter ↗AP
2021-08-12Labeling · Supplement 4 · standard — Letter ↗AP
2021-07-29Labeling · Supplement 3 · standard — Letter ↗AP
2018-08-22Labeling · Supplement 2 · standard — Label ↗AP
2017-12-15Labeling · Supplement 1 · standard — Letter ↗AP
2015-06-18Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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