Treats infections caused by susceptible strains of the designated microorganisms in the…. ANDA 204764, held by Fresenius Kabi USA. Linezolid.
As of Nov 15, 2026, ANDA 204764 (Linezolid), held by Fresenius Kabi USA, was first approved by FDA on Mar 15, 2016, with 5 approved supplements and 0 published complete response letters.
Linezolid injection is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid injection is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG/300ML (2MG/ML) · solution;intravenous | Linezolid | Rx |
| Feb 3, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 16, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 15, 2016 | 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
