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Data updated: Mar 10, 2026

ANAPROX DS

NAPROXEN SODIUM
Immunology Approved 1980-09-04
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
45
Years on Market

Details

Status
Prescription
First Approved
1980-09-04
Routes
ORAL
Dosage Forms
TABLET

Companies

ATNAHS PHARMA US
Active Ingredient: NAPROXEN SODIUM

ANAPROX DS Approval History

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What ANAPROX DS Treats

7 indications

ANAPROX DS is approved for 7 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Arthritis
  • Back Pain
  • Menstrual Cramps
  • Headache
  • Toothache
  • Common Cold
  • Fever
Source: FDA Label

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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.

ANAPROX DS FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

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

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Data Sources

FDA Approval: NDA018164 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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