HYDROCODONE BITARTRATE AND IBUPROFEN (hydrocodone bitartrate)
Development Insights
Details
- Status
- Prescription
- First Approved
- 2003-04-11
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
HYDROCODONE BITARTRATE AND IBUPROFEN Approval History
What HYDROCODONE BITARTRATE AND IBUPROFEN Treats
7 FDA approvalsOriginally approved for its first indication in 2003 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Apr 2003)
- • Approved indication (Dec 2003)
- • Approved indication (Mar 2004)
- • Approved indication (Nov 2006)
- • Approved indication (Jun 2010)
- • Approved indication (May 2013)
- • Approved indication (Jun 2016)
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06585163 | QEV-817-101 5R44DA055336 | Ph 1 | not yet recruiting | Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension |
| NCT01081912 results posted | ZX002-0801 | Ph 3 | completed | Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain |
| NCT01115569 results posted | ZX002-0802 | Ph 3 | completed | Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYDROCODONE BITARTRATE AND IBUPROFEN FDA Label Details
Track HYDROCODONE BITARTRATE AND IBUPROFEN with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment