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General MedicationsTOPICALStandard

AMELUZ

AMINOLEVULINIC ACID HYDROCHLORIDE

Standard Dose
10%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMELUZ is listed in Drugs@FDA under application 208081 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength GEL;TOPICAL - 10% Sponsor BIOFRONTERA Submission history Latest submission status date: 2024-10-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMELUZ is listed in Drugs@FDA under application 208081 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength GEL;TOPICAL - 10% Sponsor BIOFRONTERA Submission history Latest submission status date: 2024-10-04 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.