TheraRadar
Data updated: May 26, 2026

CASSIPA (buprenorphine hydrochloride)

CNS Approved 2018-09-07
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Discontinued
First Approved
2018-09-07
Routes
SUBLINGUAL
Dosage Forms
FILM

Companies

Teva
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE , NALOXONE HYDROCHLORIDE

CASSIPA Approval History

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

What CASSIPA Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
🔬

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.

CASSIPA FDA Label Details

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Data Sources

FDA Approval: NDA208042 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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