Source facts
FDA issued an approval letter for BORTEZOMIB on 2026-02-11. The source metadata identifies ANDA 219167 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
BORTEZOMIB — FDA Approval Letter (ANDA 219167)
Issued to GLAND. Application is approved as submitted.
Issued
February 11, 2026Application
ANDA 505j • 219167
Product
BORTEZOMIB
Company
GLAND
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for BORTEZOMIB?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 219167.
- 3Submission: original application.
- 4Sponsor: GLAND.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the BORTEZOMIB approval letter
Is BORTEZOMIB FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 219167 for BORTEZOMIB, sponsored by GLAND, on February 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 219167?
ANDA 219167 is the application under which FDA issued this approval letter for BORTEZOMIB to GLAND. The letter is dated February 11, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.