ANDA 207526, held by Novel Labs Inc. Linezolid.
As of Nov 15, 2026, ANDA 207526 (Linezolid), held by Novel Labs Inc, was first approved by FDA on Aug 22, 2016, with 4 approved supplements and 0 published complete response letters.
Linezolid tablets are 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 formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
| May 23, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 23, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 23, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 23, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 22, 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
