ANDA 210378, held by Macleods Pharms. Linezolid.
As of Nov 15, 2026, ANDA 210378 (Linezolid), held by Macleods Pharms, was first approved by FDA on Oct 10, 2024, with 0 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
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
