Ketorolac Tromethamine

Relieves ocular itching due to seasonal allergic conjunctivitis. ANDA 76583, held by Sandoz. Ketorolac Tromethamine.

As of Nov 15, 2026, ANDA 76583 (Ketorolac Tromethamine), held by Sandoz, was first approved by FDA on Nov 5, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 5, 2009
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for:

The temporary relief of ocular itching due to seasonal allergic conjunctivitis.
The treatment of inflammation following cataract surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 5, 2009	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ketorolac Tromethamine0.5% · solution/drops;ophthalmic	Ketorolac Tromethamine	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 13, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 5, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 76583
Drugs@FDA: Overview at FDA
Company: Sandoz

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