TheraRadar
Data updated: May 26, 2026

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (hydrocodone bitartrate)

Trial Activity: Stable 1 active trials
Pain Approved 2014-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

M.D. Anderson Cancer Center conducting 1 trials (33%)
3 indications explored (Focused)
→ intra-abdominal cancer (1 trials)
→ pain (1 trials)
→ chronic pain (1 trials)
4
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2014-04-29
Routes
ORAL
Dosage Forms
SOLUTION

Companies

TRIS PHARMA INC PADAGIS US MAYNE PHARMA INC SCIEGEN PHARMS
Active Ingredient: HYDROCODONE BITARTRATE , PSEUDOEPHEDRINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2014 to 2025
Mar 2025 SUPPL
Label · Labeling
Dec 2023 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label · Labeling

What HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE Treats

4 FDA approvals

Originally approved for its first indication in 2014 . Covers 4 distinct patient populations.

  • Other (4)
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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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 PSEUDOEPHEDRINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA203839 → Trials: ClinicalTrials.gov →

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