Data updated: Mar 10, 2026
EMBEDA
MORPHINE SULFATE
Approved 2009-08-13
2
Indications
--
Phase 3 Trials
1
Priority Reviews
16
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2009-08-13
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
EMBEDA Approval History
Loading approval history...
What EMBEDA Treats
2 FDA approvalsOriginally approved for its first indication in 2009 . Covers 2 distinct patient populations.
- Other (2)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
EMBEDA FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.