PROBUPHINE (buprenorphine hydrochloride) · REACX PHARMS
PROBUPHINE is FDA-approved to treat 1 condition (same as BELBUCA).
Details
- Status
- Discontinued
- First Approved
- 2016-05-26
- Routes
- IMPLANTATION
- Dosage Forms
- IMPLANT
PROBUPHINE Approval History
What PROBUPHINE Treats
1 indicationsPROBUPHINE is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as BELBUCA (same active ingredient).
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.
PROBUPHINE FDA Label Details
Indications & Usage
FDA Label (PDF)PROBUPHINE is FDA-approved to treat 1 condition — same approved indications as BELBUCA.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.