Ceptaz

NDA 50646, held by Glaxosmithkline. Ceftazidime.

As of Nov 13, 2026, NDA 50646 (Ceptaz), held by Glaxosmithkline, was first approved by FDA on Sep 27, 1990, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1990
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Sep 27, 1990	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Ceptaz500MG/VIAL · injectable;injection	Ceftazidime	Discontinued
Ceptaz1GM/VIAL · injectable;injection	Ceftazidime	Discontinued
Ceptaz2GM/VIAL · injectable;injection	Ceftazidime	Discontinued
Ceptaz10GM/VIAL · injectable;injection	Ceftazidime	Discontinued

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 29, 2002	Supplement 14Labeling · Standard review	Approved	Label Letter
Feb 22, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 23, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 26, 1998	Supplement 8Labeling · Standard review	Approved	None posted
Nov 25, 1997	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 3, 1997	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 24, 1996	Supplement 11Labeling · Standard review	Approved	None posted
Sep 11, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Aug 20, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Jun 20, 1996	Supplement 10Labeling · Standard review	Approved	None posted
Jun 20, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Oct 20, 1994	Supplement 5Labeling · Standard review	Approved	None posted
Sep 7, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Sep 10, 1992	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 9, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 9, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 27, 1990	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 50646
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