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FDA Orange Book · active-ingredient family

Milrinone lactate

Milrinone lactate is approved as 2 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER · NDA 020343

2

Brand (NDA)

26

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×4SANOFI AVENTIS USNDA 020343—Aug 09, 1994
PRIMACORRLDSANOFI AVENTIS USNDA 019436—Dec 31, 1987

Generic (ANDA) products (26)

ProductApplicantApplicationTEApproved
MILRINONE LACTATE IN DEXTROSE 5%×2CAPLINANDA 219170APSep 02, 2025
MILRINONE LACTATESHANDONGANDA 216373APJan 23, 2023
MILRINONE LACTATECAPLINANDA 214380APApr 16, 2021
MILRINONE LACTATE IN DEXTROSE 5%×2EUGIA PHARMAANDA 209666APSep 03, 2020
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER×2GLANDANDA 213585APJul 16, 2020
MILRINONE LACTATEMEITHEALANDA 211671APMar 24, 2020
MILRINONE LACTATEHOSPIRAANDA 203280APSep 03, 2014
MILRINONE LACTATEHIKMA FARMACEUTICAANDA 077966APDec 03, 2010
MILRINONE LACTATE IN PLASTIC CONTAINER×2HIKMA FARMACEUTICAANDA 090038APJan 21, 2010
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER×2HIKMAANDA 078113APMay 21, 2008
MILRINONE LACTATEGLAND PHARMA LTDANDA 077190—Oct 31, 2006
MILRINONE LACTATE IN DEXTROSE 5%×2WOODWARDANDA 077151—Jul 20, 2005
MILRINONE LACTATEBAXTER HLTHCARE CORPANDA 076427—Sep 21, 2004
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERB BRAUNANDA 076414—Aug 18, 2004
MILRINONE LACTATEMYLAN INSTITUTIONALANDA 076428—Jun 16, 2003
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERBAXTER HLTHCAREANDA 076259—Aug 08, 2002
MILRINONE LACTATEINTL MEDICATEDANDA 076013—Aug 02, 2002
MILRINONE LACTATEFRESENIUS KABI USAANDA 075936APMay 28, 2002
MILRINONE LACTATEHIKMAANDA 075530—May 28, 2002
MILRINONE LACTATEHIKMAANDA 075660APMay 28, 2002
MILRINONE LACTATEHIKMAANDA 075852—May 28, 2002
MILRINONE LACTATEHOSPIRAANDA 075830—May 28, 2002
MILRINONE LACTATEHOSPIRAANDA 075884—May 28, 2002
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER×2BAXTER HLTHCAREANDA 075834APMay 28, 2002
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINERHIKMAANDA 075510—May 28, 2002
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER×2HOSPIRAANDA 075885—May 28, 2002

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.

Milrinone lactate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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