Treats infections caused by penicillinase-producing staphylococci. ANDA 216845, held by Aurobindo Pharma. Dicloxacillin Sodium.
As of Nov 15, 2026, ANDA 216845 (Dicloxacillin Sodium), held by Aurobindo Pharma, was first approved by FDA on Sep 23, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2022 | Original application | Approved |
| Dicloxacillin SodiumEQ 250MG BASE · capsule;oral | Dicloxacillin Sodium | Rx |
| Dicloxacillin SodiumEQ 500MG BASE · capsule;oral | Dicloxacillin 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
