FDA — authorised 9 August 1994
- Application: NDA020343
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Primacor in United States
FDA authorised Primacor on 9 August 1994
Marketing authorisations
FDA — authorised 28 May 2002
- Application: ANDA075884
- Marketing authorisation holder: HOSPIRA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075510
- Marketing authorisation holder: HIKMA
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075885
- Marketing authorisation holder: HOSPIRA
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075530
- Marketing authorisation holder: HIKMA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075830
- Marketing authorisation holder: HOSPIRA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075834
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 2002
- Application: ANDA075852
- Marketing authorisation holder: HIKMA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 2002
- Application: ANDA076013
- Marketing authorisation holder: INTL MEDICATED
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 August 2002
- Application: ANDA076259
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 July 2005
- Application: ANDA077151
- Marketing authorisation holder: WOODWARD
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 May 2008
- Application: ANDA078113
- Marketing authorisation holder: HIKMA
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 January 2010
- Application: ANDA090038
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Status: approved
FDA — authorised 3 December 2010
- Application: ANDA077966
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 2014
- Application: ANDA203280
- Marketing authorisation holder: HOSPIRA
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 March 2020
- Application: ANDA211671
- Marketing authorisation holder: MEITHEAL
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2020
- Application: ANDA213585
- Marketing authorisation holder: GLAND
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 2020
- Application: ANDA209666
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2021
- Application: ANDA214380
- Marketing authorisation holder: CAPLIN
- Local brand name: MILRINONE LACTATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 June 2025
- Application: ANDA216373
- Marketing authorisation holder: SHANDONG
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Primacor, manufactured by Shandong, for manufacturing (CMC) purposes on 2025-06-05. This approval was granted under the standard expedited pathway. The application number for this approval is ANDA216373.
FDA — authorised 2 September 2025
- Application: ANDA219170
- Marketing authorisation holder: CAPLIN
- Local brand name: MILRINONE LACTATE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
Primacor 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 Primacor approved in United States?
Yes. FDA authorised it on 9 August 1994; FDA authorised it on 28 May 2002; FDA authorised it on 28 May 2002.
Who is the marketing authorisation holder for Primacor in United States?
SANOFI AVENTIS US holds the US marketing authorisation.