Issued to KENVUE BRANDS. Application is approved as submitted.
Posted by FDA
June 16, 2026Application
NDA 505b1 • 019835
Product
ZYRTEC ALLERGY / ZYRTEC HIVES
Company
KENVUE BRANDS
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 019835 for ZYRTEC ALLERGY / ZYRTEC HIVES, sponsored by KENVUE BRANDS,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 019835 is the application under which FDA issued this approval letter for ZYRTEC ALLERGY / ZYRTEC HIVES to KENVUE BRANDS. FDA posted the letter on June 16, 2026; the posting date is not the decision date.
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.