FDA — authorised 31 May 1996
- Application: NDA020338
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 Adapalene Gel in United States
FDA authorised Adapalene Gel on 31 May 1996
Marketing authorisations
FDA — authorised 31 May 1996
- Application: NDA020380
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 May 2000
- Application: NDA020748
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 19 June 2007
- Application: NDA021753
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 17 March 2010
- Application: NDA022502
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 2 June 2010
- Application: ANDA090962
- Marketing authorisation holder: P AND L
- Status: supplemented
FDA — authorised 1 July 2010
- Application: ANDA091314
- Marketing authorisation holder: GLENMARK PHARMS INC
- Status: supplemented
FDA — authorised 14 June 2012
- Application: ANDA200298
- Marketing authorisation holder: ENCUBE ETHICALS
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is Adapalene Gel approved in United States?
Yes. FDA authorised it on 31 May 1996; FDA authorised it on 31 May 1996; FDA authorised it on 26 May 2000.
Who is the marketing authorisation holder for Adapalene Gel in United States?
GALDERMA LABS LP holds the US marketing authorisation.