Ketorolac Tromethamine

ANDA 74801, held by Hospira. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 74801 (Ketorolac Tromethamine), held by Hospira, was first approved by FDA on Jun 5, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1997
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
Jun 5, 1997	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


Sep 23, 1999	Supplement 4Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 3Labeling	Approved	None posted
Aug 11, 1997	Supplement 2Labeling	Approved	None posted
Jun 12, 1997	Supplement 1Labeling	Approved	None posted
Jun 5, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74801
Drugs@FDA: Overview at FDA
Company: Hospira

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