Acular Ls

NDA 21528, held by Abbvie. Ketorolac Tromethamine.

As of Nov 14, 2026, NDA 21528 (Acular Ls), held by Abbvie, was first approved by FDA on May 30, 2003, with 3 approved supplements and 0 published complete response letters.

First approved: May 30, 2003
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Acular Ls0.4% · solution/drops;ophthalmic	Ketorolac Tromethamine	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Mar 5, 2021	Supplement 8Labeling · Standard review	Approved	Letter Label
May 25, 2016	Supplement 7Labeling · Standard review	Approved	Label
Dec 1, 2008	Supplement 5Labeling · Standard review	Approved	Letter
May 30, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21528
Drugs@FDA: Overview at FDA
Company: AbbVie

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