ANDA 207354, held by Nang Kuang Pharm Co. Linezolid.
As of Nov 15, 2026, ANDA 207354 (Linezolid), held by Nang Kuang Pharm Co, was first approved by FDA on Dec 20, 2016, with 8 approved supplements and 0 published complete response letters.
Linezolid injection 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2016 | Original application | Approved | None posted |
| Feb 3, 2025 | Supplement 15Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 28, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 28, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 20, 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
