FDA — authorised 18 May 1998
- Application: NDA020718
- Marketing authorisation holder: MSD SUB MERCK
- Local brand name: INTEGRILIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Integrilin in United States
FDA authorised Integrilin on 18 May 1998
Marketing authorisations
FDA — authorised 18 May 1998
- Marketing authorisation holder: SCHERING
- Status: approved
FDA — authorised 5 June 2015
- Application: ANDA091555
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 June 2015
- Application: ANDA090854
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 December 2015
- Application: ANDA206127
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2017
- Application: ANDA204589
- Marketing authorisation holder: RISING
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 November 2017
- Application: ANDA205557
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 March 2018
- Application: ANDA204693
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 July 2018
- Application: ANDA203258
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 2019
- Application: ANDA209864
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 March 2019
- Application: ANDA204362
- Marketing authorisation holder: USV
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 2019
- Application: ANDA204361
- Marketing authorisation holder: USV
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 March 2020
- Application: ANDA207864
- Marketing authorisation holder: HYBIO
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 September 2021
- Application: ANDA213081
- Marketing authorisation holder: SHUANGCHENG
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 May 2024
- Application: ANDA213599
- Marketing authorisation holder: MEITHEAL
- Local brand name: EPTIFIBATIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Integrilin 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 Integrilin approved in United States?
Yes. FDA authorised it on 18 May 1998; FDA authorised it on 18 May 1998; FDA authorised it on 5 June 2015.
Who is the marketing authorisation holder for Integrilin in United States?
MSD SUB MERCK holds the US marketing authorisation.