Treats infections caused by penicillinase producing staphylococci. ANDA 207148, held by Wockhardt Bio AG. Oxacillin Sodium.
As of Nov 15, 2026, ANDA 207148 (Oxacillin Sodium), held by Wockhardt Bio AG, was first approved by FDA on Nov 24, 2017, 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 Test Methods ). 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 |
|---|---|---|---|
| Nov 24, 2017 | Original application | Approved |
| 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
