Source facts
FDA issued an approval letter for XYZAL ALLERGY 24HR on 2026-03-09. The source metadata identifies NDA 209090 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XYZAL ALLERGY 24HR — FDA Approval Letter (NDA 209090)
Issued to CHATTEM SANOFI. Application is approved as submitted.
Issued
March 9, 2026Application
NDA 505b1 • 209090
Product
XYZAL ALLERGY 24HR
Company
CHATTEM SANOFI
Stage
Final Decision
Assyro regulatory brief
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 209090.
- 3Submission: supplement.
- 4Sponsor: CHATTEM SANOFI.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the XYZAL ALLERGY 24HR approval letter
Is XYZAL ALLERGY 24HR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 209090 for XYZAL ALLERGY 24HR, sponsored by CHATTEM SANOFI, on March 9, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 209090?
NDA 209090 is the application under which FDA issued this approval letter for XYZAL ALLERGY 24HR to CHATTEM SANOFI. The letter is dated March 9, 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.