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FDA NDA · NDA209817

NUZYRA

omadacycline

Sponsor: PARATEK PHARMS

APPLICATION
NDA209817
TYPE
NDA
ORIGINAL APPROVAL
2018-10-02
LATEST ACTION
2026-05-13
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

NUZYRA · ReferencePrescription
OMADACYCLINE TOSYLATE EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2026-05-13Efficacy · Supplement 18 · standard — Letter ↗AP
2025-03-31Labeling · Supplement 17 · standard — Label ↗AP
2021-05-27Efficacy · Supplement 10 · standard — Letter ↗AP
2021-01-11Labeling · Supplement 11 · standard — Letter ↗AP
2020-10-20Labeling · Supplement 8 · standard — Letter ↗AP
2020-09-02Labeling · Supplement 7 · standard — Letter ↗AP
2019-06-13Labeling · Supplement 3 · standard — Label ↗AP
2019-06-13Labeling · Supplement 1 · standard — Label ↗AP
2019-06-13Labeling · Supplement 2 · standard — Label ↗AP
2018-10-02Type 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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