Amikacin Sulfate

ANDA 64045, held by Meitheal. Amikacin Sulfate.

As of Nov 15, 2026, ANDA 64045 (Amikacin Sulfate), held by Meitheal, was first approved by FDA on Sep 28, 1993, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 28, 1993
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Sep 28, 1993	Original application	Approved	None posted

Products

2 strengths and forms


Amikacin SulfateEQ 50MG BASE/ML · injectable;injection	Amikacin Sulfate	Discontinued
Amikacin SulfateEQ 250MG BASE/ML · injectable;injection	Amikacin Sulfate	Rx

All 9 submissions, including labeling and manufacturing supplements


Feb 10, 2023	Supplement 40Labeling · Standard review	Approved	None posted
Jan 24, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Jan 24, 2023	Supplement 34Labeling · Standard review	Approved	None posted
May 29, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Feb 20, 2013	Supplement 24Labeling · Standard review	Approved	None posted
May 17, 2012	Supplement 18Manufacturing	Approved	None posted
Jul 3, 1996	Supplement 2Manufacturing	Approved	None posted
Jun 2, 1995	Supplement 1Manufacturing	Approved	None posted
Sep 28, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 64045
Drugs@FDA: Overview at FDA
Company: Meitheal Pharmaceuticals

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