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US FDA source recordAL · Approval Letter

ZYRTEC ALLERGY / ZYRTEC HIVES — FDA Approval Letter (NDA 019835)

Issued to KENVUE BRANDS. Application is approved as submitted.

Issued

June 16, 2026

Application

NDA 505b1 • 019835

Product

ZYRTEC ALLERGY / ZYRTEC HIVES

Company

KENVUE BRANDS

Stage

Final Decision

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What did FDA decide for ZYRTEC ALLERGY / ZYRTEC HIVES?

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Source facts

FDA issued an approval letter for ZYRTEC ALLERGY, ZYRTEC HIVES on 2026-06-16. The source metadata identifies NDA 019835 as a supplement. Review the exact FDA letter for the approved conditions and labeling.

Key details in this letter

  • 1FDA action: approval.
  • 2Application: NDA 019835.
  • 3Submission: supplement.
  • 4Sponsor: KENVUE BRANDS.

Suggested next step

Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.

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Built from structured FDA metadata and deterministic source-text signals. Topic matches are navigation aids, not legal or regulatory conclusions. Verify material decisions against the original FDA document.

FDAPDFUpdated Jul 30, 2026

FDA source document

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Common questions about the ZYRTEC ALLERGY / ZYRTEC HIVES approval letter

Is ZYRTEC ALLERGY / ZYRTEC HIVES FDA approved?

This letter documents an FDA approval action: FDA approved NDA 019835 for ZYRTEC ALLERGY / ZYRTEC HIVES, sponsored by KENVUE BRANDS, on June 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.

What is NDA 019835?

NDA 019835 is the application under which FDA issued this approval letter for ZYRTEC ALLERGY / ZYRTEC HIVES to KENVUE BRANDS. The letter is dated June 16, 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.