Linezolid

ANDA 206097, held by Zydus Pharms. Linezolid.

As of Nov 15, 2026, ANDA 206097 (Linezolid), held by Zydus Pharms, was first approved by FDA on Feb 22, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 22, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 22, 2017	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Linezolid600MG · tablet;oral	Linezolid	Rx

All 5 submissions, including labeling and manufacturing supplements


Jul 28, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Jul 28, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jan 7, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jan 7, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Feb 22, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 206097
Drugs@FDA: Overview at FDA
Company: Zydus 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