FDA — authorised 13 September 1995
- Application: NDA020428
- Marketing authorisation holder: ALMIRALL
- Local brand name: AZELEX
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Azelex in United States
FDA authorised Azelex on 13 September 1995
Marketing authorisations
FDA — authorised 24 December 2002
- Application: NDA021470
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 19 November 2018
- Application: ANDA204637
- Marketing authorisation holder: GLENMARK SPECLT
- Status: approved
FDA — authorised 19 November 2018
- Application: ANDA208011
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: AZELAIC ACID
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 November 2018
- Application: ANDA208724
- Marketing authorisation holder: ENCUBE
- Local brand name: AZELAIC ACID
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 23 August 2019
- Application: ANDA210549
- Marketing authorisation holder: SUN PHARMA CANADA
- Status: approved
FDA — authorised 1 December 2020
- Application: NDA207071
- Marketing authorisation holder: LEO PHARMA AS
- Indication: Labeling
- Status: approved
Azelex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Azelex approved in United States?
Yes. FDA authorised it on 13 September 1995; FDA authorised it on 24 December 2002; FDA authorised it on 19 November 2018.
Who is the marketing authorisation holder for Azelex in United States?
ALMIRALL holds the US marketing authorisation.