Ketorolac Tromethamine

ANDA 75299, held by Hikma. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 75299 (Ketorolac Tromethamine), held by Hikma, was first approved by FDA on Nov 3, 1999, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 3, 1999
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 3, 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 8 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Sep 21, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Sep 21, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 4Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Sep 12, 2000	Supplement 1Manufacturing	Approved	None posted
Sep 12, 2000	Supplement 2Manufacturing	Approved	None posted
Nov 3, 1999	Original application	Approved	Letter

Identifiers

Application: ANDA 75299
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