Ketorolac Tromethamine

ANDA 74993, held by Hospira. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 74993 (Ketorolac Tromethamine), held by Hospira, was first approved by FDA on Jan 27, 1999, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1999
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 27, 1999	Original application	Approved	Letter

Products

2 strengths and forms


Ketorolac Tromethamine15MG/ML · injectable;injection	Ketorolac Tromethamine	Discontinued
Ketorolac Tromethamine30MG/ML · injectable;injection	Ketorolac Tromethamine	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 52Labeling · Standard review	Approved	None posted
Nov 21, 2022	Supplement 48Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 39Labeling · Standard review	Approved	None posted
May 20, 2016	Supplement 19Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 20Labeling · Standard review	Approved	None posted
May 29, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Apr 30, 2012	Supplement 16Manufacturing	Approved	None posted
Mar 14, 2003	Supplement 6Labeling	Approved	None posted
Jul 3, 2002	Supplement 4Manufacturing	Approved	None posted
Feb 14, 2001	Supplement 3Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 2Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 1Manufacturing	Approved	None posted
Jan 27, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 74993
Drugs@FDA: Overview at FDA
Company: Hospira

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