Ketorolac Tromethamine

ANDA 75228, held by Hikma. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 75228 (Ketorolac Tromethamine), held by Hikma, was first approved by FDA on Apr 26, 1999, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 26, 1999
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
Apr 26, 1999	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Ketorolac Tromethamine	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Jul 11, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Nov 9, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Mar 8, 2011	Supplement 11Labeling	Approved	None posted
Aug 5, 2008	Supplement 10Labeling	Approved	None posted
Jul 21, 2007	Supplement 9Labeling	Approved	None posted
Feb 7, 2007	Supplement 8Labeling	Approved	None posted
Apr 3, 2001	Supplement 1Manufacturing	Approved	None posted
Apr 26, 1999	Original application	Approved	None posted

Identifiers

Application: ANDA 75228
Drugs@FDA: Overview at FDA
Company: Hikma

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