Amikacin Sulfate

ANDA 63263, held by Hospira. Amikacin Sulfate.

As of Nov 15, 2026, ANDA 63263 (Amikacin Sulfate), held by Hospira, was first approved by FDA on Nov 30, 1994, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1994
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Nov 30, 1994	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Mar 10, 2004	Supplement 12Labeling	Approved	None posted
May 13, 2003	Supplement 11Labeling	Approved	None posted
Oct 25, 2002	Supplement 10Manufacturing	Approved	None posted
Sep 27, 2002	Supplement 9Labeling	Approved	None posted
Mar 22, 2001	Supplement 8Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 7Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 5Manufacturing	Approved	None posted
Jan 2, 2000	Supplement 6Labeling	Approved	None posted
Jun 18, 1997	Supplement 4Manufacturing	Approved	None posted
Oct 3, 1996	Supplement 2Manufacturing	Approved	None posted
Nov 30, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 63263
Drugs@FDA: Overview at FDA
Company: Hospira

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