Sprix

Manages moderate to moderately severe pain. NDA 22382, held by Cosette. Ketorolac Tromethamine.

As of Nov 13, 2026, NDA 22382 (Sprix), held by Cosette, was first approved by FDA on May 14, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: May 14, 2010
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Limitations of Use Sprix is not for use in pediatric patients less than 2 years of age.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
May 14, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sprix15.75MG/SPRAY · spray, metered;nasal	Ketorolac Tromethamine	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 22Labeling · Standard review	Approved	Label Medication Guide Letter
Apr 28, 2021	Supplement 21Labeling · Standard review	Approved	Label Letter
Jan 22, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
May 9, 2016	Supplement 12Labeling · Standard review	Approved	Label Letter
May 9, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
May 11, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 21, 2014	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 29, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 2, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
May 14, 2010	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22382
Drugs@FDA: Overview at FDA
Company: Cosette

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