FDA — authorised 13 July 2018
- Application: ANDA208257
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% in United States
FDA authorised ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% on 13 July 2018
Marketing authorisations
FDA — authorised 6 August 2018
- Application: ANDA208272
- Marketing authorisation holder: TORRENT
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA208213
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA208180
- Marketing authorisation holder: MICRO LABS
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2020
- Application: ANDA208247
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA208303
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2022
- Application: ANDA208299
- Marketing authorisation holder: PRINSTON INC
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 September 2022
- Application: ANDA208256
- Marketing authorisation holder: MSN
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2023
- Application: ANDA213298
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA212490
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: ROFLUMILAST
- Indication: TABLET — ORAL
- Status: approved
Other Dermatology approved in United States
Frequently asked questions
Is ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% approved in United States?
Yes. FDA authorised it on 13 July 2018; FDA authorised it on 6 August 2018; FDA authorised it on 23 November 2018.
Who is the marketing authorisation holder for ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% in United States?
PHARMOBEDIENT holds the US marketing authorisation.