Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090038
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MILRINONE LACTATE IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
MILRINONE LACTATE IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/21/2010 ORIG-1 Approval

Label is not available on this site.

MILRINONE LACTATE IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209666 AUROBINDO PHARMA LTD
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 075834 BAXTER HLTHCARE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 213585 GLAND PHARMA LTD
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 075885 HOSPIRA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078113 WEST-WARD PHARMS INT
MILRINONE LACTATE IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090038 HIKMA FARMACEUTICA

INJECTABLE;INJECTION; EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209666 AUROBINDO PHARMA LTD
MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 077151 WOODWARD
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 075834 BAXTER HLTHCARE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 213585 GLAND PHARMA LTD
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 075885 HOSPIRA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 078113 WEST-WARD PHARMS INT
MILRINONE LACTATE IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription No AP 090038 HIKMA FARMACEUTICA

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