Ticar

NDA 50497, held by Glaxosmithkline. Ticarcillin Disodium.

As of Nov 13, 2026, NDA 50497 (Ticar), held by Glaxosmithkline, was first approved by FDA on Nov 9, 1976, with 23 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1976
Review: Standard
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Nov 9, 1976	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

5 strengths and forms


TicarEQ 1GM BASE/VIAL · injectable;injection	Ticarcillin Disodium	Discontinued
TicarEQ 3GM BASE/VIAL · injectable;injection	Ticarcillin Disodium	Discontinued
TicarEQ 6GM BASE/VIAL · injectable;injection	Ticarcillin Disodium	Discontinued
TicarEQ 20GM BASE/VIAL · injectable;injection	Ticarcillin Disodium	Discontinued
TicarEQ 30GM BASE/VIAL · injectable;injection	Ticarcillin Disodium	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Jan 3, 2003	Supplement 60Manufacturing · Standard review	Approved	None posted
Feb 8, 2002	Supplement 58Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 57Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 56Manufacturing · Standard review	Approved	None posted
Feb 5, 1998	Supplement 55Manufacturing · Standard review	Approved	None posted
Dec 23, 1997	Supplement 53Manufacturing · Standard review	Approved	None posted
Aug 29, 1997	Supplement 54Manufacturing · Standard review	Approved	None posted
Sep 4, 1996	Supplement 52Manufacturing · Standard review	Approved	None posted
Feb 6, 1996	Supplement 51Manufacturing · Standard review	Approved	None posted
Nov 9, 1995	Supplement 49Labeling · Standard review	Approved	None posted
Nov 16, 1994	Supplement 50Manufacturing · Standard review	Approved	None posted
Apr 13, 1993	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 7, 1993	Supplement 47Manufacturing · Standard review	Approved	None posted
Dec 30, 1992	Supplement 45Labeling · Standard review	Approved	None posted
Dec 30, 1992	Supplement 44Labeling · Standard review	Approved	None posted
Dec 30, 1992	Supplement 42Labeling · Standard review	Approved	None posted
Dec 22, 1992	Supplement 46Manufacturing · Standard review	Approved	None posted
May 28, 1992	Supplement 41Manufacturing · Standard review	Approved	None posted
Jan 14, 1992	Supplement 37Labeling · Standard review	Approved	None posted
Jan 2, 1992	Supplement 40Manufacturing · Standard review	Approved	None posted
Jan 2, 1992	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 26, 1990	Supplement 39Manufacturing · Standard review	Approved	None posted
Aug 30, 1989	Supplement 33Manufacturing · Standard review	Approved	None posted
Nov 9, 1976	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 50497
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