Ketorolac Tromethamine

Manages moderately severe acute pain. ANDA 78299, held by Onesource Specialty. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 78299 (Ketorolac Tromethamine), held by Onesource Specialty, was first approved by FDA on Jul 16, 2007, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2007
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Acute Pain in Adult Patients Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 16, 2007	Original application	Approved	None posted

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 8Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Sep 5, 2012	Supplement 2Labeling	Approved	None posted
Jul 16, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78299
Drugs@FDA: Overview at FDA
Company: OneSource Specialty

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