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PRIMACOR

NDA

MILRINONE LACTATE | N019436 | SANOFI AVENTIS US LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

FARMHISPANIA SAMILRINONE

DMF 143191999

W R GRACE AND CO -CONNMILRINONE USP

DMF 143751999

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDMILRINONE

DMF 197262006

EMCURE PHARMACEUTICALS LTDMILRINONE USP

DMF 299052015

BOEHRINGER INGELHEIM CHEMICALS INCInactiveMILRINONE

DMF 140231999

SAI LIFE SCIENCES LTDInactiveMILRINONE

DMF 197092006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 31, 1987

No patent or exclusivity listings for this strength.