FDA — authorised 9 May 2014
- Application: NDA050767
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
🇺🇸 Cleocin in United States
FDA authorised Cleocin on 9 May 2014
Marketing authorisations
FDA — authorised 12 February 2020
- Application: ANDA209846
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 29 July 2020
- Application: ANDA211872
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Status: approved
FDA — authorised 20 October 2023
- Application: NDA216632
- Marketing authorisation holder: BAUSCH
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 13 June 2025
- Application: ANDA219612
- Marketing authorisation holder: CARNEGIE
- Status: approved
Cleocin 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 Cleocin approved in United States?
Yes. FDA authorised it on 9 May 2014; FDA authorised it on 12 February 2020; FDA authorised it on 29 July 2020.
Who is the marketing authorisation holder for Cleocin in United States?
PFIZER holds the US marketing authorisation.