Linezolid

ANDA 205154, held by Steriscience. Linezolid.

As of Nov 15, 2026, ANDA 205154 (Linezolid), held by Steriscience, was first approved by FDA on Dec 6, 2017, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2017
Review: Standard
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
Dec 6, 2017	Original application	Approved	Letter

Products

2 strengths and forms


Linezolid200MG/100ML (2MG/ML) · solution;intravenous	Linezolid	Rx
Linezolid600MG/300ML (2MG/ML) · solution;intravenous	Linezolid	Rx

All 9 submissions, including labeling and manufacturing supplements


Apr 9, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Feb 12, 2024	Supplement 13Labeling · Standard review	Approved	None posted
May 31, 2022	Supplement 9Labeling · Standard review	Approved	None posted
May 31, 2022	Supplement 8Labeling · Standard review	Approved	None posted
May 31, 2022	Supplement 6Labeling · Standard review	Approved	None posted
May 31, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Jun 27, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Jun 27, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Dec 6, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 205154
Drugs@FDA: Overview at FDA
Company: Steriscience

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