Linezolid

ANDA 200222, held by Teva Pharms. Linezolid.

As of Nov 15, 2026, ANDA 200222 (Linezolid), held by Teva Pharms, was first approved by FDA on Jun 27, 2012, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2012
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
Jun 27, 2012	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Linezolid600MG/300ML (2MG/ML) · solution;intravenous	Linezolid	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 4, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 4, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jun 26, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jan 5, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Jan 5, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jun 27, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 200222
Drugs@FDA: Overview at FDA
Company: Teva 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