Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075834
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription AP No Yes
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75834_Milrinone%20Lactate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75834_Milrinone%20Lactate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075834_milrinone-lactate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2008 SUPPL-6 Labeling

Label is not available on this site.

03/24/2004 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/28/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75834_Milrinone%20Lactate_Prntlbl.pdf

MILRINONE LACTATE IN DEXTROSE 5% 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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