FDA Orange Book · active-ingredient family
Milrinone lactate
Milrinone lactate: 2 brands, 26 generics; first approved Dec 31, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
26
Listed patents
0
Presentations
39
Brand (NDA) products
Originator applications
- SANOFI AVENTIS USNDA 02034319944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 15MG BASE/100ML INJECTABLE INJECTION Discontinued — EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — - PRIMACORRLDSANOFI AVENTIS USNDA 0194361987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- CAPLINANDA 21917020252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - MILRINONE LACTATESHANDONGANDA 2163732023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MILRINONE LACTATECAPLINANDA 2143802021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - EUGIA PHARMAANDA 20966620202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - GLANDANDA 21358520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - MILRINONE LACTATEMEITHEALANDA 2116712020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MILRINONE LACTATEHOSPIRAANDA 2032802014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MILRINONE LACTATERSHIKMA FARMACEUTICAANDA 0779662010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - HIKMA FARMACEUTICAANDA 09003820102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - HIKMAANDA 07811320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - MILRINONE LACTATEGLAND PHARMA LTDANDA 0771902006
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - WOODWARDANDA 07715120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEBAXTER HLTHCARE CORPANDA 0764272004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - B BRAUNANDA 0764142004
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEMYLAN INSTITUTIONALANDA 0764282003
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 0762592002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEINTL MEDICATEDANDA 0760132002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEFRESENIUS KABI USAANDA 0759362002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MILRINONE LACTATEHIKMAANDA 0755302002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEHIKMAANDA 0756602002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Rx AP - MILRINONE LACTATEHIKMAANDA 0758522002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEHOSPIRAANDA 0758302002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - MILRINONE LACTATEHOSPIRAANDA 0758842002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued — - BAXTER HLTHCAREANDA 07583420022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Rx AP - HIKMAANDA 0755102002
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07588520022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued — EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
39 yr 4 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 1987–2025 across 28 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2693%
Milrinone lactate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
