Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075834
Company: BAXTER HLTHCARE

Products on ANDA 075834

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075834

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.

Labels for ANDA 075834

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

Therapeutic Equivalents for ANDA 075834

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	EUGIA PHARMA
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	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	EUGIA PHARMA
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	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