# GLEOLAN
> **NDA208630** · New Drug Application · Sponsor: NXDC · Approved 2017-06-06
## Drug
- **FDA Application Number:** NDA208630
- **Application type:** New Drug Application
- **Brand name:** GLEOLAN
- **Generic name:** AMINOLEVULINIC ACID HYDROCHLORIDE
- **Active ingredients:** AMINOLEVULINIC ACID HYDROCHLORIDE
- **Dosage form:** FOR SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NXDC
- **Manufacturer:** Medexus Pharma, Inc.
- **First approval:** 2017-06-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208630)
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