FDA — authorised 7 April 1986
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Clindamycin 2-Palmitate in United States
FDA authorised Clindamycin 2-Palmitate on 7 April 1986
Marketing authorisations
FDA — authorised 21 November 2007
- Application: ANDA062644
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
FDA — authorised 13 March 2014
- Application: ANDA203513
- Marketing authorisation holder: AMNEAL PHARMS
- Status: approved
FDA — authorised 11 May 2018
- Application: ANDA207047
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 24 August 2022
- Application: ANDA202409
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 15 April 2024
- Application: ANDA206958
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
The FDA approved Clindamycin 2-Palmitate for marketing in the United States on April 15, 2024. Chartwell RX is the marketing authorisation holder. The approval was granted under the standard expedited pathway. The indication approved is for labeling, but the specific indication is not reported.
Clindamycin 2-Palmitate 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 Clindamycin 2-Palmitate approved in United States?
Yes. FDA authorised it on 7 April 1986; FDA authorised it on 21 November 2007; FDA authorised it on 13 March 2014.
Who is the marketing authorisation holder for Clindamycin 2-Palmitate in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.