Ketorolac Tromethamine

ANDA 77201, held by Apotex Inc. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 77201 (Ketorolac Tromethamine), held by Apotex Inc, was first approved by FDA on Oct 14, 2005, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 14, 2005
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 14, 2005	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine30MG/ML · injectable;injection	Ketorolac Tromethamine	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Jun 28, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Jun 28, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 4Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Oct 14, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 77201
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