Cedax

NDA 50685, held by Burke Therap. Ceftibuten Dihydrate.

As of Nov 13, 2026, NDA 50685 (Cedax), held by Burke Therap, was first approved by FDA on Dec 20, 1995, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1995
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Dec 20, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
CedaxEQ 400MG BASE · capsule;oral	Ceftibuten Dihydrate	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 4, 2010	Supplement 12Labeling · Standard review	Approved	Letter
Feb 10, 2009	Supplement 11Labeling · Standard review	Approved	Label Letter
May 19, 2000	Supplement 8Labeling · Standard review	Approved	None posted
Jul 23, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 16, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Sep 3, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
May 21, 1997	Supplement 3Labeling · Standard review	Approved	None posted
Dec 26, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 9, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Dec 20, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 50685
Drugs@FDA: Overview at FDA
Company: Burke Therapeutics

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