FDA — authorised 15 January 1999
- Marketing authorisation holder: OTSUKA
- Status: approved
🇺🇸 Pletal in United States
FDA authorised Pletal on 15 January 1999
Marketing authorisations
FDA — authorised 23 November 2004
- Application: ANDA077022
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 November 2004
- Application: ANDA077027
- Marketing authorisation holder: TEVA
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 November 2004
- Application: ANDA077028
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 December 2004
- Application: ANDA077030
- Marketing authorisation holder: APOTEX
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 2005
- Application: ANDA077024
- Marketing authorisation holder: HIKMA
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 November 2005
- Application: ANDA077310
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 March 2006
- Application: ANDA077208
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2006
- Application: ANDA077323
- Marketing authorisation holder: RISING
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 2008
- Application: ANDA077021
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 28 September 2009
- Application: ANDA077708
- Marketing authorisation holder: SANKALP LIFECARE
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2012
- Application: ANDA077722
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2012
- Application: ANDA077831
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CILOSTAZOL
- Indication: TABLET — ORAL
- Status: approved
Pletal in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Pletal approved in United States?
Yes. FDA authorised it on 15 January 1999; FDA authorised it on 23 November 2004; FDA authorised it on 24 November 2004.
Who is the marketing authorisation holder for Pletal in United States?
OTSUKA holds the US marketing authorisation.