Dicloxacillin Sodium

Treats infections caused by penicillinase-producing staphylococci. ANDA 62286, held by Chartwell Rx. Dicloxacillin Sodium.

As of Nov 15, 2026, ANDA 62286 (Dicloxacillin Sodium), held by Chartwell Rx, was first approved by FDA on Jun 3, 1982, with 14 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1982
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jun 3, 1982	Original application	Approved	None posted

Products

2 strengths and forms


Dicloxacillin SodiumEQ 250MG BASE · capsule;oral	Dicloxacillin Sodium	Rx
Dicloxacillin SodiumEQ 500MG BASE · capsule;oral	Dicloxacillin Sodium	Rx

All 15 submissions, including labeling and manufacturing supplements


Sep 29, 2015	Supplement 81Labeling · Standard review	Approved	None posted
Sep 29, 2015	Supplement 82Labeling · Standard review	Approved	None posted
Mar 17, 2009	Supplement 78Labeling	Approved	None posted
Oct 21, 2004	Supplement 76Labeling	Approved	None posted
Mar 14, 2002	Supplement 70Manufacturing	Approved	None posted
Feb 20, 2002	Supplement 68Manufacturing	Approved	None posted
May 15, 2001	Supplement 67Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 66Manufacturing	Approved	None posted
Dec 10, 1997	Supplement 65Manufacturing	Approved	None posted
Aug 27, 1996	Supplement 64Manufacturing	Approved	None posted
May 15, 1996	Supplement 63Manufacturing	Approved	None posted
Mar 10, 1992	Supplement 61Labeling	Approved	None posted
Oct 10, 1991	Supplement 62Labeling	Approved	None posted
Dec 15, 1988	Supplement 60Manufacturing	Approved	None posted
Jun 3, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 62286
Drugs@FDA: Overview at FDA
Company: Chartwell 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