Treats infections caused by penicillinase-producing staphylococci. ANDA 200002, held by Onesource Specialty. Nafcillin Sodium.
As of Nov 15, 2026, ANDA 200002 (Nafcillin Sodium), held by Onesource Specialty, was first approved by FDA on Apr 7, 2014, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY — Susceptibility Test Methods. Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 2014 | Original application | Approved | None posted |
| Nafcillin SodiumEQ 1GM BASE/VIAL · injectable;injection | Nafcillin Sodium | Rx |
| Nafcillin SodiumEQ 2GM BASE/VIAL · injectable;injection | Nafcillin 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
