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General MedicationsTOPICALStandard

ZYCLARA

IMIQUIMOD

Standard Dose
2.5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ZYCLARA is listed in Drugs@FDA under application 022483 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IMIQUIMOD Form and strength CREAM;TOPICAL - 2.5% Sponsor BAUSCH Submission history Latest submission status date: 2024-09-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZYCLARA is listed in Drugs@FDA under application 022483 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IMIQUIMOD Form and strength CREAM;TOPICAL - 2.5% Sponsor BAUSCH Submission history Latest submission status date: 2024-09-16 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.