Ketorolac Tromethamine

ANDA 74802, held by Hospira. Ketorolac Tromethamine.

First approved: Jun 5, 1997
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jun 5, 1997	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine15MG/ML · injectable;injection	Ketorolac Tromethamine	Rx
Ketorolac Tromethamine30MG/ML · injectable;injection	Ketorolac Tromethamine	Rx

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 59Labeling · Standard review	Approved	None posted
Nov 15, 2022	Supplement 52Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 48Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 40Labeling · Standard review	Approved	None posted
Dec 14, 2014	Supplement 38Labeling · Standard review	Approved	Label
May 29, 2013	Supplement 37Labeling · Standard review	Approved	None posted
Mar 14, 2003	Supplement 22Labeling	Approved	None posted
Dec 16, 2002	Supplement 18Manufacturing	Approved	None posted
Oct 25, 2002	Supplement 20Manufacturing	Approved	None posted
Jul 29, 2002	Supplement 19Manufacturing	Approved	None posted
Feb 4, 2002	Supplement 16Manufacturing	Approved	None posted
Sep 17, 2001	Supplement 17Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 13Manufacturing	Approved	None posted
Mar 22, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 6, 2001	Supplement 14Manufacturing	Approved	None posted
Feb 14, 2001	Supplement 15Manufacturing	Approved	None posted
Sep 25, 2000	Supplement 11Manufacturing	Approved	None posted
Jan 7, 2000	Supplement 4Labeling	Approved	None posted
Jan 7, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 10, 1999	Supplement 9Labeling	Approved	None posted
Dec 10, 1999	Supplement 8Manufacturing	Approved	None posted
Dec 10, 1999	Supplement 7Manufacturing	Approved	None posted
Dec 10, 1999	Supplement 6Manufacturing	Approved	None posted
Dec 10, 1999	Supplement 5Manufacturing	Approved	None posted
Sep 23, 1999	Supplement 10Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 2Labeling	Approved	None posted
Jun 12, 1997	Supplement 1Labeling	Approved	None posted
Jun 5, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74802
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters