Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213585
Company: GLAND PHARMA LTD

Products on ANDA 213585

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	No
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	MILRINONE LACTATE	EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213585

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