CODEINE SULFATE
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-07-16
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
CODEINE SULFATE Approval History
What CODEINE SULFATE Treats
3 FDA approvalsOriginally approved for its first indication in 2009 . Covers 3 distinct patient populations.
- Other (3)
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT01009697 | CODE-T15/30/60-PVFS-1 | Ph 1 | completed | Dose Linearity Study of Codeine Sulfate Under Fasted Conditions |
| NCT01010152 | CODE-T30-PVFS-1 | Ph 1 | completed | Comparative Bioavailability Study of Codeine Sulfate |
| NCT01009892 | CODE-T60-PVFS/FD-1 | Ph 1 | completed | Food Effect Study of Codeine Sulfate |
| NCT01009853 | CODE-T15-PVFS-1 | Ph 1 | completed | Steady State Study of Codeine Sulfate |
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.
CODEINE SULFATE FDA Label Details
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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