# AZELEX
> **NDA020428** · New Drug Application · Sponsor: ALMIRALL · Approved 1995-09-13
## Drug
- **FDA Application Number:** NDA020428
- **Application type:** New Drug Application
- **Brand name:** AZELEX
- **Generic name:** AZELAIC ACID
- **Active ingredients:** AZELAIC ACID
- **Dosage form:** CREAM
- **Route:** TOPICAL
- **Marketing status:** Prescription
- **Sponsor:** ALMIRALL
- **Manufacturer:** Almirall, LLC
- **First approval:** 1995-09-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020428)
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