Source facts
FDA issued an approval letter for CHILDREN'S ADVIL, CHILDREN'S ADVIL-FLAVORED on 2026-06-29. The source metadata identifies NDA 020589 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED — FDA Approval Letter (NDA 020589)
Issued to HALEON US HOLDINGS. Application is approved as submitted.
Issued
June 29, 2026Application
NDA 505b1 • 020589
Product
CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED
Company
HALEON US HOLDINGS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 020589.
- 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 CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED approval letter
Is CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020589 for CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED, sponsored by HALEON US HOLDINGS, on June 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020589?
NDA 020589 is the application under which FDA issued this approval letter for CHILDREN'S ADVIL / CHILDREN'S ADVIL-FLAVORED to HALEON US HOLDINGS. The letter is dated June 29, 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.