FDA — authorised 20 October 1971
- Application: NDA016921
- Marketing authorisation holder: VALEANT INTL
- Local brand name: RETIN-A
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 Retin-A in United States
FDA authorised Retin-A on 20 October 1971
Marketing authorisations
FDA — authorised 20 October 1971
- Marketing authorisation holder: VALEANT INTL
- Status: approved
FDA — authorised 19 July 1974
- Application: NDA017522
- Marketing authorisation holder: VALEANT BERMUDA
- Local brand name: RETIN-A
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 18 April 1975
- Application: NDA017579
- Marketing authorisation holder: VALEANT INTL
- Local brand name: RETIN-A
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 17 October 1978
- Application: NDA017955
- Marketing authorisation holder: BAUSCH
- Local brand name: RETIN-A
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 16 September 1988
- Application: NDA019049
- Marketing authorisation holder: BAUSCH
- Local brand name: RETIN-A
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 December 1995
- Application: NDA019963
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: RENOVA
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 January 1997
- Application: NDA020404
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: AVITA
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 February 1997
- Application: NDA020475
- Marketing authorisation holder: BAUSCH
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 29 January 1998
- Application: NDA020400
- Marketing authorisation holder: RISING
- Local brand name: AVITA
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 19 June 1998
- Application: ANDA074873
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: TRETINOIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 24 December 1998
- Application: ANDA075264
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 December 1998
- Application: ANDA075265
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 December 1998
- Application: ANDA075213
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 25 January 1999
- Application: ANDA075260
- Marketing authorisation holder: WOCKHARDT
- Local brand name: TRETINOIN
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 22 February 2000
- Application: ANDA075529
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 August 2000
- Application: NDA021108
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: RENOVA
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 June 2002
- Application: ANDA075589
- Marketing authorisation holder: PADAGIS US
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 15 September 2005
- Application: ANDA076498
- Marketing authorisation holder: ZO SKIN HEALTH
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 21 June 2007
- Application: ANDA077684
- Marketing authorisation holder: BARR LABS INC
- Local brand name: TRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 July 2007
- Application: NDA022070
- Marketing authorisation holder: DOW PHARM
- Local brand name: ATRALIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 22 March 2010
- Application: ANDA090098
- Marketing authorisation holder: ALLERGAN
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 11 October 2012
- Application: ANDA202209
- Marketing authorisation holder: ALLERGAN
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 24 October 2012
- Application: ANDA201687
- Marketing authorisation holder: PH HEALTH
- Local brand name: TRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 March 2013
- Application: NDA050802
- Marketing authorisation holder: BAUSCH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 July 2013
- Application: ANDA202026
- Marketing authorisation holder: RISING
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 17 July 2013
- Application: ANDA202567
- Marketing authorisation holder: RISING
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 August 2015
- Application: ANDA207955
- Marketing authorisation holder: MYLAN
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 May 2016
- Application: NDA017340
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 December 2016
- Application: ANDA208279
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TRETINOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 January 2023
- Application: ANDA215713
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 August 2023
- Application: ANDA215609
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN MICROSPHERE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA217804
- Marketing authorisation holder: ALEMBIC
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 13 January 2025
- Application: ANDA218246
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 27 February 2025
- Application: ANDA218245
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 March 2025
- Application: ANDA217587
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 3 March 2025
- Application: ANDA217588
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 10 July 2025
- Application: ANDA217831
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 August 2025
- Application: ANDA218399
- Marketing authorisation holder: ALEMBIC
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 10 February 2026
- Application: ANDA217833
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 25 March 2026
- Application: ANDA217832
- Marketing authorisation holder: ENCUBE
- Local brand name: TRETINOIN
- Indication: CREAM — TOPICAL
- Status: approved
Retin-A in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Retin-A approved in United States?
Yes. FDA authorised it on 20 October 1971; FDA authorised it on 20 October 1971; FDA authorised it on 19 July 1974.
Who is the marketing authorisation holder for Retin-A in United States?
VALEANT INTL holds the US marketing authorisation.