FDA.reportPublic FDA data

AMINOLEVULINIC ACID Pharmacologic Class Indexing

Class set ID
395cd9c3-6968-4e8b-88a2-348c7efe66c6
Version
3
Effective date
20220324
Type
Indexing - Pharmacologic Class

Mapped DailyMed Labels#

Label, Manufacturer, Effective table
LabelManufacturerEffectiveSPL version
These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN ® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]NX DEVELOPMENT CORP202601298
These highlights do not include all the information needed to use AMELUZ safely and effectively. See full prescribing information for AMELUZ. AMELUZ ® (aminolevulinic acid hydrochloride) topical gel Initial U.S. Approval: 1999Biofrontera Inc. | Glaropharm AG2025122231
These highlights do not include all the information needed to use LEVULAN ® KERASTICK ® safely and effectively. See full prescribing information for LEVULAN KERASTICK. LEVULAN KERASTICK (aminolevulinic acid HCl) for Topical Solution, 20% Initial U.S. Approval: 1999Sun Pharmaceutical Industries, Inc2024091221
These highlights do not include all the information needed to use GLEOLAN safely and effectively. See full prescribing information for GLEOLAN. GLEOLAN® (aminolevulinic acid hydrochloride) for oral solution Initial U.S. Approval: [1999]Medexus Pharma, Inc. | NX Development Corp202405033