Source facts
FDA issued an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-03-27. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF — FDA Approval Letter (NDA 021621)
Issued to KENVUE BRANDS. Application is approved as submitted.
Issued
March 27, 2026Application
NDA 505b1 • 021621
Product
CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF
Company
KENVUE BRANDS
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 021621.
- 3Submission: supplement.
- 4Sponsor: KENVUE BRANDS.
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 ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF approval letter
Is CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021621 for CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF, sponsored by KENVUE BRANDS, on March 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021621?
NDA 021621 is the application under which FDA issued this approval letter for CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF to KENVUE BRANDS. The letter is dated March 27, 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.