FDA — authorised 6 November 1967
- Marketing authorisation holder: STI PHARMA LLC
- Status: approved
🇺🇸 Myambutol in United States
FDA authorised Myambutol on 6 November 1967
Marketing authorisations
FDA — authorised 26 June 1978
- Application: NDA016320
- Marketing authorisation holder: KANCHAN HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 1 February 2002
- Application: ANDA075095
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 17 June 2009
- Application: ANDA078939
- Marketing authorisation holder: LUPIN
- Status: approved
Myambutol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Myambutol approved in United States?
Yes. FDA authorised it on 6 November 1967; FDA authorised it on 26 June 1978; FDA authorised it on 1 February 2002.
Who is the marketing authorisation holder for Myambutol in United States?
STI PHARMA LLC holds the US marketing authorisation.