FDA.reportPublic FDA data

AMINOLEVULINIC ACID HYDROCHLORIDE - Food and Drug Administration

Set ID
c09e7fc3-90f5-4f9d-96f4-e1a857de4102
Type
Indexing - product concept
Effective date
2023-07-18
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2026-10-13
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2026-09-25
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2026-09-17
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2026-08-26
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2026-07-23
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]Product nameNX DEVELOPMENT CORP2026-01-29
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2025-12-22
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: 1999Product nameBiofrontera Inc. | Glaropharm AG2025-12-18
These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995Product nameProficient Rx LP2025-12-01
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: 1999Product nameSun Pharmaceutical Industries, Inc2024-09-12
These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995Product nameProficient Rx LP2024-07-01
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]Product nameMedexus Pharma, Inc. | NX Development Corp2024-05-03
Levulan® Kerastick® (aminolevulinic acid HCl) for Topical Solution, 20% For Topical Use Only Not for Opthalmic UseProduct nameDUSA2006-10-08