Linezolid

ANDA 200904, held by Sandoz. Linezolid.

As of Nov 15, 2026, ANDA 200904 (Linezolid), held by Sandoz, was first approved by FDA on Jul 16, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Linezolid injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use:

Linezolid is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Jul 16, 2015	Original application	Approved	Letter Letter
Jul 16, 2015	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 9 submissions, including labeling and manufacturing supplements


Jul 3, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Dec 22, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Dec 22, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Dec 22, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Dec 22, 2023	Supplement 14Labeling · Standard review	Approved	None posted
May 28, 2019	Supplement 4Labeling · Standard review	Approved	None posted
May 28, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Jul 16, 2015	Original application	Approved	Letter Letter
Jul 16, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 200904
Drugs@FDA: Overview at FDA
Company: Sandoz

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