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FDA NDA · NDA205435

SIVEXTRO

tedizolid phosphate

Sponsor: CUBIST PHARMS LLC

APPLICATION
NDA205435
TYPE
NDA
ORIGINAL APPROVAL
2014-06-20
LATEST ACTION
2026-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SIVEXTRO · ReferencePrescription
TEDIZOLID PHOSPHATE 200MG · TABLET · ORAL

Approval history

2026-02-27Labeling · Supplement 19 · standard — Letter ↗AP
2025-04-04Efficacy · Supplement 16 · standard — Label ↗AP
2021-11-17Labeling · Supplement 14 · standard — Letter ↗AP
2020-10-22Labeling · Supplement 13 · standard — Label ↗AP
2020-06-19Efficacy · Supplement 12 · standard — Letter ↗AP
2019-09-09Labeling · Supplement 11 · standard — Letter ↗AP
2019-03-06Efficacy · Supplement 10 · standard — Label ↗AP
2017-08-12Labeling · Supplement 8 · standard — Label ↗AP
2017-08-12Labeling · Supplement 7 · standard — Label ↗AP
2016-11-01Manufacturing (CMC) · Supplement 4 · standardAP
2016-10-28Labeling · Supplement 3 · standard — Letter ↗AP
2016-09-16Labeling · Supplement 6 · standard — Letter ↗AP
2016-06-05Labeling · Supplement 5 · standard — Letter ↗AP
2015-08-11Manufacturing (CMC) · Supplement 2 · priorityAP
2015-03-04Labeling · Supplement 1 · standard — Letter ↗AP
2014-06-20Type 1 - New Molecular Entity · 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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