FDA — authorised 23 November 2015
- Application: ANDA206075
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
🇺🇸 CLOBETASOL in United States
FDA authorised CLOBETASOL on 23 November 2015
Marketing authorisations
FDA — authorised 27 October 2017
- Application: ANDA210199
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 28 November 2017
- Application: NDA209483
- Marketing authorisation holder: PRIMUS PHARMS
- Status: approved
FDA — authorised 2 October 2019
- Application: ANDA211191
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 17 February 2022
- Application: ANDA211240
- Marketing authorisation holder: QUAGEN
- Status: approved
FDA
- Status: approved
CLOBETASOL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CLOBETASOL approved in United States?
Yes. FDA authorised it on 23 November 2015; FDA authorised it on 27 October 2017; FDA authorised it on 28 November 2017.
Who is the marketing authorisation holder for CLOBETASOL in United States?
NOVEL LABS INC holds the US marketing authorisation.