Amikacin Sulfate

ANDA 64099, held by Hospira. Amikacin Sulfate.

As of Nov 15, 2026, ANDA 64099 (Amikacin Sulfate), held by Hospira, was first approved by FDA on Jun 20, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 20, 1995
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
Jun 20, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amikacin SulfateEQ 250MG BASE/ML · injectable;injection	Amikacin Sulfate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 14, 2001	Supplement 1Manufacturing	Approved	None posted
Jun 20, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 64099
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