Ketorolac Tromethamine

Manages moderately severe acute pain. ANDA 74754, held by Teva. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 74754 (Ketorolac Tromethamine), held by Teva, was first approved by FDA on May 16, 1997, with 13 approved supplements and 0 published complete response letters.

First approved: May 16, 1997
Supplements approved: 13
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 tablets, USP and other treatment options before deciding to use ketorolac tromethamine tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac tromethamine tablets, USP are 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
May 16, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine10MG · tablet;oral	Ketorolac Tromethamine	Rx

All 14 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Dec 6, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 20Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 18Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Aug 20, 2012	Supplement 14Labeling	Approved	None posted
Jun 19, 2007	Supplement 10Labeling	Approved	None posted
Feb 6, 2007	Supplement 9Labeling	Approved	None posted
Aug 30, 2001	Supplement 5Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 4Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 3Manufacturing	Approved	None posted
Jun 9, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 1Manufacturing	Approved	None posted
May 16, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74754
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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