FDA — authorised 6 November 1967
- Application: NDA016320
- Marketing authorisation holder: KANCHAN HLTHCARE
- Status: supplemented
🇺🇸 ETHAMBUTOL HYDROCHLORIDE in United States
FDA authorised ETHAMBUTOL HYDROCHLORIDE on 6 November 1967
Marketing authorisations
FDA — authorised 30 November 1999
- Application: ANDA075095
- Marketing authorisation holder: EPIC PHARMA LLC
- Status: supplemented
FDA — authorised 26 November 2001
- Application: ANDA076057
- Marketing authorisation holder: BARR
- Local brand name: ETHAMBUTOL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2009
- Application: ANDA078939
- Marketing authorisation holder: LUPIN
- Local brand name: ETHAMBUTOL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
ETHAMBUTOL HYDROCHLORIDE 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 ETHAMBUTOL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 6 November 1967; FDA authorised it on 30 November 1999; FDA authorised it on 26 November 2001.
Who is the marketing authorisation holder for ETHAMBUTOL HYDROCHLORIDE in United States?
KANCHAN HLTHCARE holds the US marketing authorisation.