aminolevulinic acid hydrochloride

FDA Drug Profile — AMELUZ, LEVULAN KERASTICK

aminolevulinic acid hydrochloride is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including AMELUZ, LEVULAN KERASTICK. Available dosage forms: gel, for solution, kit.

Drug Details

Generic Name
aminolevulinic acid hydrochloride
Brand Names
AMELUZ, LEVULAN KERASTICK
Application Number
NDA208081
Sponsor
Biofrontera Inc.
NDC Codes
4
Dosage Forms
GEL, FOR SOLUTION, KIT
Routes
TOPICAL
Active Ingredients
AMINOLEVULINIC ACID HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. LEVULAN KERASTICK for topical solution, a porphyrin precursor, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the face or scalp, or actinic keratoses of the upper extremities. ( 1 )