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General MedicationsTOPICALStandard

LIDOCAINE

LIDOCAINE

Standard Dose
5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview LIDOCAINE is listed in Drugs@FDA under application 216484 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient LIDOCAINE Form and strength PATCH;TOPICAL - 5% Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-10-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview LIDOCAINE is listed in Drugs@FDA under application 216484 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LIDOCAINE Form and strength PATCH;TOPICAL - 5% Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2025-10-06 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.