TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

APADAZ

ACETAMINOPHEN
Approved 2018-02-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Discontinued
First Approved
2018-02-23
Routes
ORAL
Dosage Forms
TABLET

Companies

ZEVRA THERAP
Active Ingredient: ACETAMINOPHEN , BENZHYDROCODONE HYDROCHLORIDE

APADAZ Approval History

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What APADAZ Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
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Active Pipeline

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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.

APADAZ FDA Label Details

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APADAZ Patents & Exclusivity

Latest Patent: Feb 2031

Patents (45 active)

US8461137 Expires Feb 22, 2031
US9132125 Expires Jul 1, 2030
US9549923 Expires Jul 1, 2030
US8828978 Expires Jul 1, 2030
US8748413 Expires Jul 1, 2030
+ 35 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208653 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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