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FDA NDA · NDA211109

XERAVA

Sponsor: TETRAPHASE PHARMS

APPLICATION
NDA211109
TYPE
NDA
ORIGINAL APPROVAL
2018-08-27
LATEST ACTION
2025-03-31
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

XERAVA · ReferencePrescription
ERAVACYCLINE DIHYDROCHLORIDE EQ 50MG BASE/VIAL · POWDER · INTRAVENOUS
XERAVA · ReferencePrescription
ERAVACYCLINE DIHYDROCHLORIDE EQ 100MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2025-03-31Labeling · Supplement 14 · standard — Label ↗AP
2024-12-13Labeling · Supplement 9 · standard — Label ↗AP
2020-06-03Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2019-06-18Manufacturing (CMC) · Supplement 1AP
2018-08-27Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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