Skip to main content

Caldolor FDA Approval History

Last updated by Judith Stewart, BPharm on May 17, 2023.

FDA Approved: Yes (First approved June 11, 2009)
Brand name: Caldolor
Generic name: ibuprofen
Dosage form: Intravenous Injection
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Pain, Fever

Caldolor (ibuprofen) is an intravenous formulation of the approved nonsteroidal anti-inflammatory drug ibuprofen for use in the treatment of pain and fever.

Development timeline for Caldolor

DateArticle
May 15, 2023Approval Caldolor Now FDA Approved for Treatment of Fever & Pain in Infants
Jun 12, 2009Approval Cumberland Pharmaceuticals Announces FDA Approval of Caldolor

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.