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Data updated: Nov 8, 2026

ANAPROX DS (naproxen sodium) · ATNAHS PHARMA US

Pain Approved 1980-09-04
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
46
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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Original
New Indication
New Form
Label Update
51 FDA actions from 1980 to 2024 · 1 indication expansions
Nov 2024 SUPPL
Label · Labeling
FDA Letter Label
May 2024 SUPPL
Label · Labeling
FDA Letter Label
Apr 2021 SUPPL
Label · Labeling
FDA Letter Label

What ANAPROX DS Treats

2 FDA approvals

Originally approved for its first indication in 1980 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
NCT04145518 MCUP results posted EH19-040 R01HD098193-01A1 Ph 4 completed Mechanistic Characterization of Uterine Pain
NCT04015596 results posted 2019P000623 Ph 4 terminated Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS
NCT05761574 results posted CCSPAA005199 CCSPAA005199 Ph 3 completed A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
NCT05982392 results posted 2889 Ph 2, Ph 3 completed Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain
NCT01107236 ICP-109-201 Ph 2 completed Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction
NCT03291418 ATB-346-P2GIS Ph 1, Ph 2 completed To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects
NCT01090050 results posted 112839 Ph 4 completed Treximet in the Treatment of Chronic Migraine
NCT01300546 results posted 114933 Ph 4 completed Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
NCT00692016 Keifer 13080 Ph 1 completed Fast & Fed Pharmacokinetic (PK) Study
NCT07901959 FMA-1073 Ph 1 recruiting Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
🔬

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.

ANAPROX DS FDA Label Details

This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →

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Data Sources

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

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