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General MedicationsORALStandard

GLEOLAN

AMINOLEVULINIC ACID HYDROCHLORIDE

Standard Dose
1.5GM/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GLEOLAN is listed in Drugs@FDA under application 208630 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength FOR SOLUTION;ORAL - 1.5GM/VIAL Sponsor NXDC Submission history Latest submission status date: 2024-04-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview GLEOLAN is listed in Drugs@FDA under application 208630 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength FOR SOLUTION;ORAL - 1.5GM/VIAL Sponsor NXDC Submission history Latest submission status date: 2024-04-23 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.