Amrinone Lactate

ANDA 75513, held by Hikma. Inamrinone Lactate.

As of Nov 15, 2026, ANDA 75513 (Amrinone Lactate), held by Hikma, was first approved by FDA on May 9, 2000, with 1 approved supplement and 0 published complete response letters.

First approved: May 9, 2000
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 9, 2000	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amrinone LactateEQ 5MG BASE/ML · injectable;injection	Inamrinone Lactate	Rx

All 2 submissions, including labeling and manufacturing supplements


Apr 3, 2001	Supplement 1Manufacturing	Approved	None posted
May 9, 2000	Original application	Approved	None posted

Identifiers

Application: ANDA 75513
Drugs@FDA: Overview at FDA
Company: Hikma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters