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General MedicationsORALGeneric

XYZAL

LEVOCETIRIZINE DIHYDROCHLORIDE

Standard Dose
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview XYZAL is listed in Drugs@FDA under application 022064 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient LEVOCETIRIZINE DIHYDROCHLORIDE Form and strength TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CHATTEM SANOFI Submission history Latest submission status date: 2025-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview XYZAL is listed in Drugs@FDA under application 022064 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient LEVOCETIRIZINE DIHYDROCHLORIDE Form and strength TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor CHATTEM SANOFI Submission history Latest submission status date: 2025-07-11 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.