Source facts
FDA issued an approval letter for ZYRTEC-D 12 HOUR on 2026-07-06. The source metadata identifies NDA 021150 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZYRTEC-D 12 HOUR — FDA Approval Letter (NDA 021150)
Issued to KENVUE BRANDS. Application is approved as submitted.
Issued
July 6, 2026Application
NDA 505b1 • 021150
Product
ZYRTEC-D 12 HOUR
Company
KENVUE BRANDS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZYRTEC-D 12 HOUR?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 021150.
- 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 ZYRTEC-D 12 HOUR approval letter
Is ZYRTEC-D 12 HOUR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021150 for ZYRTEC-D 12 HOUR, sponsored by KENVUE BRANDS, on July 6, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021150?
NDA 021150 is the application under which FDA issued this approval letter for ZYRTEC-D 12 HOUR to KENVUE BRANDS. The letter is dated July 6, 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.