Linezolid

ANDA 211813, held by Hetero Labs. Linezolid.

As of Nov 15, 2026, ANDA 211813 (Linezolid), held by Hetero Labs, was first approved by FDA on Oct 31, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 31, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Linezolid for oral suspension 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; Uncomplicated skin and skin structure infections; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use:

Linezolid for oral suspension is not indicated for the treatment of Gram-negative infections.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 31, 2022	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Linezolid100MG/5ML · for suspension;oral	Linezolid	Rx

All 3 submissions, including labeling and manufacturing supplements


May 22, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Nov 21, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Oct 31, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 211813
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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