Treats infections caused by susceptible strains of the designated microorganisms in the…. ANDA 205233, held by Alembic. Linezolid.
As of Nov 15, 2026, ANDA 205233 (Linezolid), held by Alembic, was first approved by FDA on Dec 21, 2015, with 2 approved supplements and 0 published complete response letters.
Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are 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 |
|---|---|---|---|
| Dec 21, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Linezolid600MG · tablet;oral | Linezolid | Rx |
| Dec 17, 2018 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 17, 2018 | 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
