FDA — authorised 27 November 1974
- Marketing authorisation holder: RANBAXY
- Status: approved
🇺🇸 Halog in United States
FDA authorised Halog on 27 November 1974
Marketing authorisations
FDA — authorised 4 May 1977
- Application: NDA017823
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: HALOG
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 June 1977
- Application: NDA017824
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: HALOG
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 June 1977
- Application: NDA017818
- Marketing authorisation holder: WESTWOOD SQUIBB
- Local brand name: HALOG
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 9 January 1978
- Application: NDA017556
- Marketing authorisation holder: SUN PHARM INDS INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 January 1980
- Application: NDA018234
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: HALOG-E
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 12 August 2019
- Application: ANDA211027
- Marketing authorisation holder: MYLAN
- Local brand name: HALCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 September 2021
- Application: ANDA214723
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HALCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA217671
- Marketing authorisation holder: ENCUBE
- Status: approved
FDA
- Application: NDA018125
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: HALOG
- Indication: OINTMENT — TOPICAL
- Status: approved
Halog 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 Halog approved in United States?
Yes. FDA authorised it on 27 November 1974; FDA authorised it on 4 May 1977; FDA authorised it on 15 June 1977.
Who is the marketing authorisation holder for Halog in United States?
RANBAXY holds the US marketing authorisation.