FDA — authorised 29 December 1999
- Application: NDA021055
- Marketing authorisation holder: BAUSCH
- Local brand name: TARGRETIN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Targretin in United States
FDA authorised Targretin on 29 December 1999
Marketing authorisations
FDA — authorised 28 June 2000
- Application: NDA021056
- Marketing authorisation holder: BAUSCH
- Local brand name: TARGRETIN
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 12 August 2014
- Application: ANDA203174
- Marketing authorisation holder: BIONPHARMA
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 May 2018
- Application: ANDA209861
- Marketing authorisation holder: ANI PHARMS
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 July 2018
- Application: ANDA209886
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 September 2018
- Application: ANDA210105
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 June 2020
- Application: ANDA203663
- Marketing authorisation holder: HIKMA
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 January 2021
- Application: ANDA209931
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 27 April 2022
- Application: ANDA215398
- Marketing authorisation holder: AMNEAL
- Local brand name: BEXAROTENE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 6 September 2024
- Application: ANDA208628
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 2024
- Application: ANDA210352
- Marketing authorisation holder: CIPLA
- Local brand name: BEXAROTENE
- Indication: CAPSULE — ORAL
- Status: approved
Targretin 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 Targretin approved in United States?
Yes. FDA authorised it on 29 December 1999; FDA authorised it on 28 June 2000; FDA authorised it on 12 August 2014.
Who is the marketing authorisation holder for Targretin in United States?
BAUSCH holds the US marketing authorisation.