GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE)
Summary
FDA approved GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) by NXDC. NDA (New Drug) approval (Labeling) on 2024-04-23. FOR SOLUTION, ORAL.
Details
Source
Drug Approval
External ID
NDA208630-7
Action Date
2024-04-23
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
GLEOLAN (generic: AMINOLEVULINIC ACID HYDROCHLORIDE), FOR SOLUTION, ORAL. Application: NDA208630
Company
Context & Analysis
Frequently Asked Questions
How often does NXDC have FDA actions?
This is the only FDA action we have on record for NXDC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA208630-7" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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