FDA — authorised 7 July 2010
- Application: ANDA090902
- Marketing authorisation holder: PADAGIS US
- Local brand name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 CLINDAMYCIN PALMITATE HYDROCHLORIDE in United States
FDA authorised CLINDAMYCIN PALMITATE HYDROCHLORIDE on 7 July 2010
Marketing authorisations
FDA — authorised 28 August 2012
- Application: ANDA201821
- Marketing authorisation holder: RISING
- Local brand name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 25 May 2016
- Application: ANDA203063
- Marketing authorisation holder: EXTROVIS
- Local brand name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA206958
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 11 May 2018
- Application: ANDA207047
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: CLINDAMYCIN PALMITATE HYDROCHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
CLINDAMYCIN PALMITATE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CLINDAMYCIN PALMITATE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 7 July 2010; FDA authorised it on 28 August 2012; FDA authorised it on 25 May 2016.
Who is the marketing authorisation holder for CLINDAMYCIN PALMITATE HYDROCHLORIDE in United States?
PADAGIS US holds the US marketing authorisation.