Dycill

ANDA 62238, held by Glaxosmithkline. Dicloxacillin Sodium.

As of Nov 15, 2026, ANDA 62238 (Dycill), held by Glaxosmithkline, was first approved by FDA on Dec 31, 1979, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1979
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 31, 1979	Original application	Approved	None posted

Products

2 strengths and forms


DycillEQ 250MG BASE · capsule;oral	Dicloxacillin Sodium	Discontinued
DycillEQ 500MG BASE · capsule;oral	Dicloxacillin Sodium	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 20, 1998	Supplement 2Manufacturing	Approved	None posted
Aug 6, 1996	Supplement 1Labeling	Approved	None posted
Dec 31, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 62238
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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