TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

OXYCET

ACETAMINOPHEN
Immunology Approved 1983-12-07
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
42
Years on Market

Details

Status
Prescription
First Approved
1983-12-07
Routes
ORAL
Dosage Forms
TABLET

Companies

SPECGX LLC
Active Ingredient: ACETAMINOPHEN , OXYCODONE HYDROCHLORIDE

OXYCET Approval History

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What OXYCET Treats

5 indications

OXYCET is approved for 5 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Headache
  • Arthritis
  • Toothache
  • Menstrual Cramps
  • Fever
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

OXYCET FDA Label Details

Pro

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache the common cold backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever

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Data Sources

FDA Approval: ANDA087463 → Label: DailyMed → Trials: ClinicalTrials.gov →

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