TheraRadar
Data updated: May 26, 2026

PROBUPHINE (buprenorphine hydrochloride)

Pain Approved 2016-05-26
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
10
Years on Market

Details

Status
Discontinued
First Approved
2016-05-26
Routes
IMPLANTATION
Dosage Forms
IMPLANT

Companies

REACX PHARMS
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE

PROBUPHINE Approval History

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

What PROBUPHINE Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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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.

PROBUPHINE FDA Label Details

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Data Sources

FDA Approval: NDA204442 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.