Linezolid

ANDA 204536, held by Amneal Pharms. Linezolid.

As of Nov 15, 2026, ANDA 204536 (Linezolid), held by Amneal Pharms, was first approved by FDA on Dec 21, 2015, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2015
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 21, 2015	Original application	Approved	Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Linezolid600MG · tablet;oral	Linezolid	Discontinued

All 7 submissions, including labeling and manufacturing supplements


May 8, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Apr 30, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Apr 30, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 30, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Dec 21, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Dec 21, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Dec 21, 2015	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 204536
Drugs@FDA: Overview at FDA
Company: Amneal 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