FDA — authorised 31 May 1996
- Application: NDA020380
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Differin in United States
FDA authorised Differin on 31 May 1996
Marketing authorisations
FDA — authorised 31 May 1996
- Application: NDA020338
- Marketing authorisation holder: GALDERMA LABS LP
- Local brand name: DIFFERIN
- Indication: SOLUTION — 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 30 June 2010
- Application: ANDA090824
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: ADAPALENE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 27 October 2014
- Application: ANDA201000
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: ADAPALENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 23 June 2016
- Application: ANDA208322
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: ADAPALENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 23 September 2016
- Application: ANDA203981
- Marketing authorisation holder: WAYLIS THERAP
- Local brand name: ADAPALENE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 8 July 2019
- Application: ANDA090962
- Marketing authorisation holder: P AND L
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 June 2020
- Application: ANDA213508
- Marketing authorisation holder: ALEMBIC
- Local brand name: ADAPALENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 May 2022
- Application: ANDA212464
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: ADAPALENE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 June 2022
- Application: ANDA214553
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 22 June 2022
- Application: ANDA209641
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: ADAPALENE AND BENZOYL PEROXIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA216632
- Marketing authorisation holder: BAUSCH
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 11 April 2024
- Application: ANDA209148
- Marketing authorisation holder: SUN PHARMA CANADA
- Indication: Labeling
- Status: approved
The FDA approved SUN PHARMA CANADA's application (ANDA209148) for Differin on April 11, 2024. This approval allows SUN PHARMA CANADA to market Differin in the United States. Differin is approved for its labeled indication, but the specific indication is not reported in the available data.
FDA — authorised 18 August 2025
- Application: ANDA214185
- Marketing authorisation holder: ALEMBIC
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved the manufacturing (CMC) indication for Differin, a product of ALEMBIC, on 18 August 2025. This approval was granted under the standard expedited pathway. The application number for this approval is ANDA214185.
Differin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Differin 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 Differin in United States?
GALDERMA LABS LP holds the US marketing authorisation.