FDA — authorised 3 June 1964
- Application: NDA015197
- Marketing authorisation holder: HIKMA
- Local brand name: AMICAR
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ε-Aminocaproic Acid (EACA) in United States
FDA authorised ε-Aminocaproic Acid (EACA) on 3 June 1964
Marketing authorisations
FDA — authorised 4 June 1964
- Application: NDA015230
- Marketing authorisation holder: HIKMA
- Local brand name: AMICAR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 June 1964
- Application: NDA015229
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AMICAR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
ε-Aminocaproic Acid (EACA) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ε-Aminocaproic Acid (EACA) approved in United States?
Yes. FDA authorised it on 3 June 1964; FDA authorised it on 4 June 1964; FDA authorised it on 8 June 1964.
Who is the marketing authorisation holder for ε-Aminocaproic Acid (EACA) in United States?
HIKMA holds the US marketing authorisation.