Treats infections caused by penicillinase-producing staphylococci. ANDA 61454, held by Chartwell Rx. Dicloxacillin Sodium.
As of Nov 15, 2026, ANDA 61454 (Dicloxacillin Sodium), held by Chartwell Rx, was first approved by FDA on Apr 1, 1971, with 6 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 |
|---|---|---|---|
| Apr 1, 1971 | Original application | Approved | None posted |
| Dicloxacillin SodiumEQ 250MG BASE · capsule;oral | Dicloxacillin Sodium | Discontinued |
| Dicloxacillin SodiumEQ 125MG BASE · capsule;oral | Dicloxacillin Sodium | Discontinued |
| Dicloxacillin SodiumEQ 500MG BASE · capsule;oral | Dicloxacillin Sodium | Discontinued |
| Jul 22, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jan 26, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jan 26, 2016 | Supplement 9Labeling | Approved | None posted |
| Jan 26, 2016 | Supplement 7Labeling | Approved | None posted |
| Jul 14, 2005 | Supplement 1Labeling | Approved | None posted |
| Jun 18, 2004 | Supplement 5Labeling | Approved | None posted |
| Apr 1, 1971 | 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
