FDA — authorised 17 June 1986
- Application: ANDA070522
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: AMINOCAPROIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Amicar in United States
FDA authorised Amicar on 17 June 1986
Marketing authorisations
FDA — authorised 9 March 1987
- Application: ANDA070010
- Marketing authorisation holder: HOSPIRA
- Local brand name: AMINOCAPROIC ACID IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 1987
- Application: ANDA071192
- Marketing authorisation holder: LUITPOLD
- Local brand name: AMINOCAPROIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 September 1998
- Application: ANDA074759
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 May 2001
- Application: ANDA075602
- Marketing authorisation holder: HIKMA
- Local brand name: AMINOCAPROIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2018
- Application: ANDA209060
- Marketing authorisation holder: SUNNY
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 August 2019
- Application: ANDA212780
- Marketing authorisation holder: AMNEAL
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 November 2019
- Application: ANDA212492
- Marketing authorisation holder: AMNEAL
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 2020
- Application: ANDA212814
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 11 August 2020
- Application: ANDA212494
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 6 November 2020
- Application: ANDA212938
- Marketing authorisation holder: MSN
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 January 2021
- Application: ANDA214140
- Marketing authorisation holder: CARNEGIE
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 February 2021
- Application: ANDA213928
- Marketing authorisation holder: CARNEGIE
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2021
- Application: ANDA212110
- Marketing authorisation holder: ADAPTIS
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 2022
- Application: ANDA213944
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: AMINOCAPROIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2022
- Application: ANDA216464
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 March 2023
- Application: ANDA214458
- Marketing authorisation holder: TARO
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 December 2023
- Application: ANDA213213
- Marketing authorisation holder: SUNNY
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA215100
- Marketing authorisation holder: MSN
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 May 2025
- Application: ANDA213216
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: AMINOCAPROIC ACID
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 August 2025
- Application: ANDA215374
- Marketing authorisation holder: ZENARA
- Local brand name: AMINOCAPROIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA070694
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: AMINOCAPROIC ACID
- Indication: Injectable — Injection
- Status: approved
Amicar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Amicar approved in United States?
Yes. FDA authorised it on 17 June 1986; FDA authorised it on 9 March 1987; FDA authorised it on 1 December 1987.
Who is the marketing authorisation holder for Amicar in United States?
ABRAXIS PHARM holds the US marketing authorisation.