FDA — authorised 16 December 2004
- Application: ANDA077123
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: HALOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Monad 3 in United States
FDA authorised Monad 3 on 16 December 2004
Marketing authorisations
FDA — authorised 16 December 2004
- Application: ANDA076872
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 December 2004
- Application: ANDA076903
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 June 2005
- Application: ANDA077109
- Marketing authorisation holder: COSETTE
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 4 August 2005
- Application: ANDA077227
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: HALOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 September 2006
- Application: ANDA077721
- Marketing authorisation holder: COSETTE
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 April 2007
- Application: ANDA078162
- Marketing authorisation holder: COSETTE
- Local brand name: HALOBETASOL PROPIONATE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 20 March 2018
- Application: ANDA209978
- Marketing authorisation holder: ENCUBE
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 24 May 2018
- Application: NDA210566
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: LEXETTE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
FDA — authorised 3 June 2020
- Application: ANDA211464
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: HALOBETASOL PROPIONATE
- Indication: LOTION — TOPICAL
- Status: approved
FDA — authorised 6 October 2020
- Application: ANDA213560
- Marketing authorisation holder: QUAGEN
- Local brand name: HALOBETASOL PROPIONATE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 11 August 2023
- Application: ANDA215266
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: HALOBETASOL PROPIONATE
- Indication: AEROSOL, FOAM — TOPICAL
- Status: approved
Frequently asked questions
Is Monad 3 approved in United States?
Yes. FDA authorised it on 16 December 2004; FDA authorised it on 16 December 2004; FDA authorised it on 16 December 2004.
Who is the marketing authorisation holder for Monad 3 in United States?
PADAGIS ISRAEL holds the US marketing authorisation.