General MedicationsTOPICALStandard
LEVULAN
AMINOLEVULINIC ACID HYDROCHLORIDE
Standard Dose
20%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LEVULAN is listed in Drugs@FDA under application 020965 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength SOLUTION;TOPICAL - 20% Sponsor SUN PHARM INDS INC Submission history Latest submission status date: 2022-05-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview LEVULAN is listed in Drugs@FDA under application 020965 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMINOLEVULINIC ACID HYDROCHLORIDE Form and strength SOLUTION;TOPICAL - 20% Sponsor SUN PHARM INDS INC Submission history Latest submission status date: 2022-05-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.