Treats infections caused by susceptible strains of the designated microorganisms in the…. ANDA 210702, held by Chartwell Rx. Linezolid.
As of Nov 15, 2026, ANDA 210702 (Linezolid), held by Chartwell Rx, was first approved by FDA on Apr 25, 2019, with 2 approved supplements and 0 published complete response letters.
Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid 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 |
|---|---|---|---|
| Apr 25, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
| Feb 19, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 1, 2019 | Supplement 1Manufacturing | Approved | None posted |
| Apr 25, 2019 | 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
