ANDA 204239, held by Hetero Labs Ltd V. Linezolid.
As of Nov 15, 2026, ANDA 204239 (Linezolid), held by Hetero Labs Ltd V, was first approved by FDA on Dec 21, 2015, with 3 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:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
| May 22, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 2, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 2, 2019 | 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
