TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FENOPROFEN CALCIUM

FENOPROFEN CALCIUM
Approved 1988-04-20
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
37
Years on Market

Details

Status
Discontinued
First Approved
1988-04-20
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

QUANTUM PHARMICS AM THERAP WATSON LABS TEVA PAR PHARM PHARMACO HALSEY RISING WARNER CHILCOTT WATSON LABS STRIDES PHARMA INTL MISEMER USL PHARMA IVAX SUB TEVA PHARMS ANI PHARMS DAVA PHARMS INC Sun Pharma
Active Ingredient: FENOPROFEN CALCIUM

FENOPROFEN CALCIUM Approval History

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What FENOPROFEN CALCIUM Treats

14 FDA approvals

Originally approved for its first indication in 1988 . Covers 14 distinct patient populations.

  • Other (14)
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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.

FENOPROFEN CALCIUM FDA Label Details

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Data Sources

FDA Approval: ANDA071738 → Trials: ClinicalTrials.gov →

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