Linezolid

ANDA 204696, held by Sagent Pharms Inc. Linezolid.

As of Nov 15, 2026, ANDA 204696 (Linezolid), held by Sagent Pharms Inc, was first approved by FDA on Mar 2, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 2, 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
Mar 2, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Feb 28, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Feb 28, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Feb 28, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jun 28, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Mar 2, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 204696
Drugs@FDA: Overview at FDA
Company: Sagent 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