Treats infections caused by penicillinase producing staphylococci. ANDA 206199, held by Fresenius Kabi USA. Oxacillin Sodium.
As of Nov 15, 2026, ANDA 206199 (Oxacillin Sodium), held by Fresenius Kabi USA, was first approved by FDA on Jul 27, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY -Susceptibility Testing ). Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxacillin SodiumEQ 10GM BASE/VIAL · injectable;injection | Oxacillin Sodium | Rx |
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
