Ketorolac Tromethamine

ANDA 77943, held by Wockhardt Bio AG. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 77943 (Ketorolac Tromethamine), held by Wockhardt Bio AG, was first approved by FDA on Mar 27, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 27, 2007
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
Mar 27, 2007	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 6Labeling · Standard review	Approved	None posted
Jun 18, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jun 18, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 29, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Mar 27, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77943
Drugs@FDA: Overview at FDA
Company: Wockhardt Bio AG

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