FDA — authorised 28 May 1997
- Application: ANDA064150
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Labeling
- Status: approved
🇺🇸 RIFAMPIN in United States
FDA authorised RIFAMPIN on 28 May 1997
Marketing authorisations
FDA — authorised 28 March 2008
- Application: ANDA065390
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Status: supplemented
FDA — authorised 21 August 2013
- Application: ANDA090034
- Marketing authorisation holder: LUPIN PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 21 August 2014
- Application: ANDA091181
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: supplemented
FDA — authorised 3 March 2016
- Application: ANDA205039
- Marketing authorisation holder: HIKMA PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 1 July 2020
- Application: ANDA065421
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 8 October 2025
- Application: NDA050627
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Labeling
- Status: approved
The FDA approved RIFAMPIN for use in the United States on 2025-10-08. The marketing authorisation holder is SANOFI AVENTIS US. The application was submitted under the standard expedited pathway. RIFAMPIN is used for the indications listed in the approved labeling.
RIFAMPIN 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 RIFAMPIN approved in United States?
Yes. FDA authorised it on 28 May 1997; FDA authorised it on 28 March 2008; FDA authorised it on 21 August 2013.
Who is the marketing authorisation holder for RIFAMPIN in United States?
EPIC PHARMA LLC holds the US marketing authorisation.