GLEOLAN
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 solutionInitial U.S. Approval: [1999]
Approved
Approval ID
cdeded66-0017-42cf-9471-13f231014323
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2021
Manufacturers
FDA
NX DEVELOPMENT CORP
DUNS: 079994320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AMINOLEVULINIC ACID HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code71469-231
Application NumberNDA208630
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 15, 2019
Generic NameAMINOLEVULINIC ACID HYDROCHLORIDE
INGREDIENTS (1)
AMINOLEVULINIC ACID HYDROCHLORIDEActive
Quantity: 1500 mg in 1 1
Code: V35KBM8JGR
Classification: ACTIB