Ketorolac Tromethamine

ANDA 74955, held by Watson Labs. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 74955 (Ketorolac Tromethamine), held by Watson Labs, was first approved by FDA on Sep 19, 1997, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1997
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 19, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Oct 18, 2019	Supplement 4Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Jul 16, 1998	Supplement 1Manufacturing	Approved	None posted
Sep 19, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74955
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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