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Data updated: Mar 10, 2026

FIORICET W/ CODEINE

ACETAMINOPHEN
Immunology Approved 1992-07-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
33
Years on Market

Details

Status
Prescription
First Approved
1992-07-30
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Teva
Active Ingredient: ACETAMINOPHEN , BUTALBITAL , CAFFEINE , CODEINE PHOSPHATE

FIORICET W/ CODEINE Approval History

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What FIORICET W/ CODEINE Treats

5 indications

FIORICET W/ CODEINE is approved for 5 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.

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

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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.

FIORICET W/ CODEINE FDA Label Details

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Indications & Usage

FDA Label (PDF)

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: NDA020232 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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