Amikacin Sulfate

ANDA 63313, held by Hikma. Amikacin Sulfate.

As of Nov 15, 2026, ANDA 63313 (Amikacin Sulfate), held by Hikma, was first approved by FDA on Apr 11, 1994, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1994
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 11, 1994	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amikacin SulfateEQ 50MG BASE/ML · injectable;injection	Amikacin Sulfate	Rx

All 6 submissions, including labeling and manufacturing supplements


Jan 24, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Nov 20, 2012	Supplement 12Labeling · Standard review	Approved	None posted
Apr 3, 2001	Supplement 3Manufacturing	Approved	None posted
Aug 4, 1997	Supplement 2Manufacturing	Approved	None posted
Feb 23, 1995	Supplement 1Manufacturing	Approved	None posted
Apr 11, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 63313
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