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As of Nov 15, 2026, ANDA 200068 (Linezolid), held by Hikma, was first approved by FDA on Jun 3, 2015, with 7 approved supplements and 0 published complete response letters.
First approved: Jun 3, 2015
Supplements approved: 7
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 ( 1. 2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1. 3); Uncomplicated skin and skin structure infections ( 1. 4); Vancomycin-resistant Enterococcus faecium infections. ( 1. 5) Limitations of Use:
Linezolid is not indicated for the treatment of Gram-negative infections.
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
