# AMELUZ
> **NDA208081** · New Drug Application · Sponsor: BIOFRONTERA · Approved 2016-05-10
## Drug
- **FDA Application Number:** NDA208081
- **Application type:** New Drug Application
- **Brand name:** AMELUZ
- **Generic name:** AMINOLEVULINIC ACID HYDROCHLORIDE
- **Active ingredients:** AMINOLEVULINIC ACID HYDROCHLORIDE
- **Dosage form:** GEL
- **Route:** TOPICAL
- **Marketing status:** Prescription
- **Sponsor:** BIOFRONTERA
- **Manufacturer:** Biofrontera Inc.
- **First approval:** 2016-05-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208081)
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