Source facts
FDA issued an approval letter for TERLIVAZ on 2026-06-11. The source metadata identifies NDA 022231 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TERLIVAZ — FDA Approval Letter (NDA 022231)
Issued to MALLINCKRODT IRELAND. Application is approved as submitted.
Issued
June 11, 2026Application
NDA 505b1 • 022231
Product
TERLIVAZ
Company
MALLINCKRODT IRELAND
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for TERLIVAZ?
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: NDA 022231.
- 3Submission: supplement.
- 4Sponsor: MALLINCKRODT IRELAND.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the TERLIVAZ approval letter
Is TERLIVAZ FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022231 for TERLIVAZ, sponsored by MALLINCKRODT IRELAND, on June 11, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 022231?
NDA 022231 is the application under which FDA issued this approval letter for TERLIVAZ to MALLINCKRODT IRELAND. The letter is dated June 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.