← FDA DRUG APPROVALS

FDA NDA · NDA205436

SIVEXTRO

tedizolid phosphate

Sponsor: CUBIST PHARMS LLC

APPLICATION
NDA205436
TYPE
NDA
ORIGINAL APPROVAL
2014-06-20
LATEST ACTION
2026-02-27
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

SIVEXTRO · ReferencePrescription
TEDIZOLID PHOSPHATE 200MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-02-27Labeling · Supplement 15 · standard — Letter ↗AP
2025-04-04Efficacy · Supplement 13 · standard — Label ↗AP
2021-11-17Labeling · Supplement 9 · standard — Letter ↗AP
2020-10-22Labeling · Supplement 8 · standard — Label ↗AP
2020-06-19Efficacy · Supplement 7 · standard — Letter ↗AP
2019-09-09Labeling · Supplement 6 · standard — Letter ↗AP
2019-03-06Efficacy · Supplement 5 · standard — Letter ↗AP
2017-08-12Labeling · Supplement 4 · standard — Label ↗AP
2017-08-12Labeling · Supplement 3 · standard — Label ↗AP
2016-10-28Labeling · Supplement 2 · standard — Letter ↗AP
2015-03-04Labeling · Supplement 1 · standard — Letter ↗AP
2014-06-20Type 3 - New Dosage Form · Original · priority — 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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