FDA — authorised 17 May 2004
- Marketing authorisation holder: MISSION PHARMA
- Status: approved
🇺🇸 Tindamax in United States
FDA authorised Tindamax on 17 May 2004
Marketing authorisations
FDA — authorised 17 May 2004
- Application: NDA021682
- Marketing authorisation holder: MISSION PHARMA
- Local brand name: TINDAMAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2004
- Application: NDA021618
- Marketing authorisation holder: MISSION PHARMA
- Local brand name: TINDAMAX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2012
- Application: ANDA202044
- Marketing authorisation holder: CHARTWELL RX
- Indication: Not Applicable
- Status: approved
FDA — authorised 9 October 2013
- Application: ANDA202489
- Marketing authorisation holder: UNIQUE
- Local brand name: TINIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2022
- Application: ANDA203808
- Marketing authorisation holder: EDENBRIDGE PHARMS
- Indication: Labeling
- Status: approved
Tindamax 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 Tindamax approved in United States?
Yes. FDA authorised it on 17 May 2004; FDA authorised it on 17 May 2004; FDA authorised it on 17 May 2004.
Who is the marketing authorisation holder for Tindamax in United States?
MISSION PHARMA holds the US marketing authorisation.