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FDA NDA · NDA208744

TIGECYCLINE

Sponsor: ACCORD HLTHCARE INC

APPLICATION
NDA208744
TYPE
NDA
ORIGINAL APPROVAL
2018-01-18
LATEST ACTION
2025-03-31
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

TIGECYCLINEDiscontinued
TIGECYCLINE 50MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-03-31Labeling · Supplement 6 · standard — Label ↗AP
2020-10-21Labeling · Supplement 3 · standard — Letter ↗AP
2018-01-18Type 5 - New Formulation or New Manufacturer · Original · standard — 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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