Orange Book product · Brand (NDA)
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
MILRINONE LACTATE
At a glance
Aug 09, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 09, 1994
32 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
MILRINONE LACTATE
Strength
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020343
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1987PRIMACORBrand (NDA)
NDA 019436 · SANOFI AVENTIS US
- 2025MILRINONE LACTATE IN DEXTROSE 5%Generic (ANDA)
ANDA 219170 · CAPLIN
- 2023MILRINONE LACTATEGeneric (ANDA)
ANDA 216373 · SHANDONG
- 2021MILRINONE LACTATEGeneric (ANDA)
ANDA 214380 · CAPLIN
- 2020MILRINONE LACTATE IN DEXTROSE 5%Generic (ANDA)
ANDA 209666 · EUGIA PHARMA
- 2020MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 213585 · GLAND
- 2020MILRINONE LACTATEGeneric (ANDA)
ANDA 211671 · MEITHEAL
- 2014MILRINONE LACTATEGeneric (ANDA)
ANDA 203280 · HOSPIRA
- 2010MILRINONE LACTATEGeneric (ANDA)
ANDA 077966 · HIKMA FARMACEUTICA
- 2010MILRINONE LACTATE IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 090038 · HIKMA FARMACEUTICA
- 2008MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078113 · HIKMA
- 2006MILRINONE LACTATEGeneric (ANDA)
ANDA 077190 · GLAND PHARMA LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
