Ketorolac Tromethamine

ANDA 77308, held by Apotex. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 77308 (Ketorolac Tromethamine), held by Apotex, was first approved by FDA on Nov 5, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2009
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
Nov 5, 2009	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine0.4% · solution/drops;ophthalmic	Ketorolac Tromethamine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 27, 2017	Supplement 7Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 28, 2013	Supplement 1Manufacturing	Approved	None posted
Nov 5, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 77308
Drugs@FDA: Overview at FDA
Company: Apotex

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