ANDA 205517, held by Alkem Labs Ltd. Linezolid.
As of Nov 15, 2026, ANDA 205517 (Linezolid), held by Alkem Labs Ltd, was first approved by FDA on Dec 21, 2015, 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 tablets are not indicated for the treatment of Gram-negative infections. The safety and efficacy of linezolid tablets formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
| Jan 16, 2025 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 5, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 5, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 5, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 23, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 31, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 21, 2015 | Original application | Approved |
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
