BORUZU (BORTEZOMIB)
Summary
FDA approved BORUZU (BORTEZOMIB) by SHILPA. NDA (New Drug) approval (Type 5 - New Formulation or New Manufacturer) on 2024-08-26. SOLUTION, INTRAVENOUS, SUBCUTANEOUS.
Details
Source
Drug Approval
External ID
NDA212782-1
Action Date
2024-08-26
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
BORUZU (generic: BORTEZOMIB), SOLUTION, INTRAVENOUS, SUBCUTANEOUS. Application: NDA212782
Company
Context & Analysis
SHILPA has 6 FDA actions in our database.
Frequently Asked Questions
How often does SHILPA have FDA actions?
SHILPA has 6 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA212782-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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