Hydrocodone Bitartrate; Ibuprofen

Sold as Vicoprofen. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 15, 2026, FDA lists 8 applications for Hydrocodone Bitartrate; Ibuprofen (sold as Vicoprofen), first approved Sep 23, 1997, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 23, 1997
Applications: 8
New uses approved: 0
Complete response letters: 0

Clinical Trials

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


An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain ServicePostsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco	Phase 3	Not yet recruiting	Dec 22, 2025
RCT: Suzetrigine vs Norco for Post-op PainPain Control · Jacob Lensing	Phase 4	Not yet recruiting	Sep 29, 2025
Prospective Opioid-Free AIS FusionAdolescent Idiopathic Scoliosis (AIS) · OrthoCarolina Research Institute, Inc.	Phase 4	Enrolling by invitation	Apr 20, 2025
Scheduled or as Needed Pain Regimen?Pain, Postoperative · Cape Fear Valley Health System	Phase 4	Active, not recruiting	Jul 11, 2024
Comparing Perioperative Outcomes in Pain ControlPost-operative Pain · University of California, San Diego	Phase 4	Active, not recruiting	Jan 19, 2023
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid ExposureOpioid Use, Opioid Dependence · Northwestern University	Phase 2	Active, not recruiting	Jul 19, 2022

Applications

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


Sep 23, 1997	VicoprofenNDA 20716 · New combination	Abbvie	13	Discontinued
Apr 11, 2003	Hydrocodone Bitartrate And IbuprofenANDA 76023	Teva	5	Discontinued
Dec 31, 2003	Hydrocodone Bitartrate And IbuprofenANDA 76604	Actavis Labs Fl Inc	17	Marketed
Mar 18, 2004	Hydrocodone Bitartrate And IbuprofenANDA 76642	Amneal Pharms Ny	27	Marketed
Nov 6, 2006	Hydrocodone Bitartrate And Ibuprofen, HydrocodoneANDA 77723	Strides Pharma	20	Discontinued
Jun 23, 2010	Hydrocodone Bitartrate And IbuprofenANDA 77454	Ani Pharms	13	Discontinued
May 28, 2013	Hydrocodone Bitartrate And IbuprofenANDA 91633	Sun Pharm Inds Inc	14	Discontinued
Jun 2, 2016	Hydrocodone Bitartrate And IbuprofenANDA 204575	Aurolife Pharma LLC	13	Marketed

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