Ketorolac Tromethamine

ANDA 78145, held by Luitpold. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 78145 (Ketorolac Tromethamine), held by Luitpold, was first approved by FDA on Jan 14, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2008
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 14, 2008	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 5 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Jun 21, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 5Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jan 14, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78145
Drugs@FDA: Overview at FDA
Company: Luitpold Pharmaceuticals

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