Source facts
FDA issued an approval letter for ALLI on 2026-03-31. The source metadata identifies NDA 021887 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ALLI — FDA Approval Letter (NDA 021887)
Issued to HALEON US HOLDINGS. Application is approved as submitted.
Issued
March 31, 2026Application
NDA 505b1 • 021887
Product
ALLI
Company
HALEON US HOLDINGS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ALLI?
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 021887.
- 3Submission: supplement.
- 4Sponsor: HALEON US HOLDINGS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ALLI approval letter
Is ALLI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021887 for ALLI, sponsored by HALEON US HOLDINGS, on March 31, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021887?
NDA 021887 is the application under which FDA issued this approval letter for ALLI to HALEON US HOLDINGS. The letter is dated March 31, 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.