Ketorolac Tromethamine

Manages moderately severe acute pain. ANDA 75784, held by Fresenius Kabi USA. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 75784 (Ketorolac Tromethamine), held by Fresenius Kabi USA, was first approved by FDA on Jan 11, 2002, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 11, 2002
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (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 8 submissions below

Date	Submission	Status	Documents
Jan 11, 2002	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Aug 26, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Aug 26, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 20Labeling · Standard review	Approved	None posted
May 11, 2016	Supplement 14Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Apr 11, 2002	Supplement 1Labeling	Approved	None posted
Jan 11, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 75784
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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