Linezolid

ANDA 78061, held by Teva Pharms USA. Linezolid.

As of Nov 15, 2026, ANDA 78061 (Linezolid), held by Teva Pharms USA, was first approved by FDA on May 18, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: May 18, 2015
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 18, 2015	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Linezolid600MG · tablet;oral	Linezolid	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Nov 14, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Oct 28, 2015	Supplement 1Manufacturing	Approved	None posted
Oct 28, 2015	Supplement 2Labeling · Standard review	Approved	None posted
May 18, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 78061
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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