Ketorolac Tromethamine

ANDA 74761, held by Mylan. Ketorolac Tromethamine.

First approved: May 16, 1997
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 16, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Apr 28, 2021	Supplement 15Labeling · Standard review	Approved	None posted
May 9, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jun 29, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Aug 20, 2012	Supplement 8Labeling	Approved	None posted
Jun 12, 2000	Supplement 2Manufacturing	Approved	None posted
Jan 29, 1998	Supplement 1Manufacturing	Approved	None posted
May 16, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74761
Drugs@FDA: Overview at FDA
Company: Mylan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters