← FDA DRUG APPROVALS

FDA NDA · NDA216974

XACDURO (COPACKAGED)

Sponsor: ENTASIS THERAP

APPLICATION
NDA216974
TYPE
NDA
ORIGINAL APPROVAL
2023-05-23
LATEST ACTION
2023-05-23
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

XACDURO (COPACKAGED) · ReferencePrescription
DURLOBACTAM SODIUM EQ 500MG BASE/VIAL, DURLOBACTAM SODIUM EQ 500MG BASE/VIAL, SULBACTAM SODIUM EQ 1GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2023-05-23Type 1 - New Molecular Entity and Type 4 - New Combination · 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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