Acetaminophen; Ibuprofen Sodium

Relieves mild to moderate pain. Sold as Combogesic Iv. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Acetaminophen; Ibuprofen Sodium (sold as Combogesic Iv), first approved Oct 17, 2023, with 0 new uses approved and 1 published complete response letter.

First approved: Oct 17, 2023
Applications: 1
New uses approved: 0
Complete response letters: 1

Clinical Trials

66 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.Caffeine, Hypoxia · Liverpool John Moores University	Phase 4	Recruiting	Nov 13, 2026
Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami	Phase 4	Not yet recruiting	Nov 12, 2026
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain ManagementPelvic Organ Prolapse (POP), Postoperative Pain · Aditi Talkad	Phase 4	Not yet recruiting	Oct 2, 2026
Suzetrigine Versus Standard Analgesia After Skin Cancer SurgeryPostoperative Pain, Acute Pain · University of Minnesota	Phase 4	Not yet recruiting	Sep 25, 2026
Post-Vasectomy Pain StudyVasectomy, NSAIDs · Columbia University	Phase 1	Recruiting	Sep 17, 2026
Post-op Analgesia of Nail Unit ProceduresNail Diseases · University of Miami	Phase 4	Not yet recruiting	Sep 15, 2026
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral PalsyCerebral Palsy, Postoperative Pain · Diskapi Yildirim Beyazit Education and Research Hospital	Not applicable	Recruiting	Sep 3, 2026
Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)Breast Cancer, Aromatase Inhibitor · Ilsan Cha hospital	Not applicable	Recruiting	Aug 27, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 17, 2023	Combogesic IvNDA 215320 · New formulation or manufacturer	Hikma	1	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jun 30, 2022	Combogesic (acetaminophen/ibuprofen)Nonclinical	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA