ANDA 206917, held by Eugia Pharma. Linezolid.
As of Nov 15, 2026, ANDA 206917 (Linezolid), held by Eugia Pharma, was first approved by FDA on Aug 4, 2016, with 6 approved supplements and 0 published complete response letters.
Linezolid 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 injection is not indicated for the treatment of Gram-negative infections. The safety and efficacy of linezolid injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG/300ML (2MG/ML) · solution;intravenous | Linezolid | Rx |
| Mar 13, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 19, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 19, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 19, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 27, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 4, 2016 | Original application | Approved | None posted |
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
