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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075513

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NDA 075513 describes AMRINONE LACTATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, and Hospira, and is included in three NDAs. Additional details are available on the AMRINONE LACTATE profile page.

The generic ingredient in AMRINONE LACTATE is inamrinone lactate. There is one drug master file entry for this compound. Additional details are available on the inamrinone lactate profile page.

Summary for 075513

Tradename:	AMRINONE LACTATE
Applicant:	Hikma
Ingredient:	inamrinone lactate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	May 9, 2000	TE:		RLD:	No

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