Dicloxacillin Sodium

ANDA 61455, held by Apothecon. Dicloxacillin Sodium.

As of Nov 15, 2026, ANDA 61455 (Dicloxacillin Sodium), held by Apothecon, was first approved by FDA on Apr 1, 1971, with 1 approved supplement and 0 published complete response letters.

First approved: Apr 1, 1971
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Apr 1, 1971	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicloxacillin SodiumEQ 62.5MG BASE/5ML · for suspension;oral	Dicloxacillin Sodium	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 30, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 1, 1971	Original application	Approved	None posted

Identifiers

Application: ANDA 61455
Drugs@FDA: Overview at FDA
Company: Apothecon

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