Treats infections caused by penicillinase producing staphylococci. ANDA 201539, held by Eugia Pharma Speclts. Oxacillin Sodium.
As of Nov 15, 2026, ANDA 201539 (Oxacillin Sodium), held by Eugia Pharma Speclts, was first approved by FDA on Jan 18, 2013, with 2 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 |
|---|---|---|---|
| Jan 18, 2013 | Original application | Approved | None posted |
| Oxacillin SodiumEQ 1GM BASE/VIAL · injectable;injection | Oxacillin Sodium | Rx |
| Oxacillin SodiumEQ 2GM BASE/VIAL · injectable;injection | Oxacillin Sodium | Rx |
| Aug 1, 2018 | Supplement 7Manufacturing | Approved | None posted |
| Apr 26, 2013 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 18, 2013 | 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
