XACDURO (SULBACTAM AND DURLOBACTAM)
Summary
FDA approved XACDURO (SULBACTAM AND DURLOBACTAM) by ENTASIS THERAP. NDA (New Drug) approval (Type 1 - New Molecular Entity and Type 4 - New Combination) on 2023-05-23. POWDER, INTRAVENOUS.
Details
Source
Drug Approval
External ID
NDA216974-1
Action Date
2023-05-23
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
XACDURO (generic: SULBACTAM AND DURLOBACTAM), POWDER, INTRAVENOUS. Application: NDA216974
Company
Context & Analysis
Frequently Asked Questions
How often does ENTASIS THERAP have FDA actions?
This is the only FDA action we have on record for ENTASIS THERAP in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA216974-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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