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Data updated: Mar 10, 2026

NAPROXEN SODIUM

NAPROXEN SODIUM
Immunology Approved 1993-08-31
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
33
Indications
--
Phase 3 Trials
32
Years on Market

Details

Status
Prescription
First Approved
1993-08-31
Routes
ORAL
Dosage Forms
TABLET, TABLET, EXTENDED RELEASE, CAPSULE

Companies

SCIEGEN PHARMS Teva IVAX SUB TEVA PHARMS AMNEAL PHARMS NY HETERO LABS LTD V PATHEON SOFTGELS WATSON LABS MARKSANS PHARMA Aurobindo Pharma BIONPHARMA Novartis ROXANE PUREPAC PHARM CONTRACT PHARMACAL Sun Pharma LNK INTL INC ONESOURCE SPECIALTY Hikma CATALENT YICHANG HUMANWELL PLD ACQUISITIONS LLC PERRIGO GLENMARK PHARMS LTD GRANULES INDIA NOVELGENIX THERAPS Dr. Reddy's PURACAP PHARM LLC ABLE HAMILTON PHARMS PLIVA PHARMOBEDIENT
Active Ingredient: NAPROXEN SODIUM

NAPROXEN SODIUM Approval History

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What NAPROXEN SODIUM Treats

7 indications

NAPROXEN SODIUM is approved for 7 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.

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

Drugs Similar to NAPROXEN SODIUM

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ANAPROX DS
NAPROXEN SODIUM
7 shared
ATNAHS PHARMA US
Shared indications:
ArthritisBack PainMenstrual Cramps +4 more
ALLZITAL
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ANEXSIA 5/325
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FIORICET W/ CODEINE
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Teva
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OXYCET
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SPECGX LLC
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PROMETHAZINE W/ DEXTROMETHORPHAN
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PHARMOBEDIENT
Shared indications:
Common ColdHeadacheFever
IMMPHENTIV
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PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
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2 shared
GENUS
Shared indications:
HeadacheFever
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
2 shared
Dr. Reddy's
Shared indications:
HeadacheFever
CALDOLOR
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1 shared
CUMBERLAND PHARMS
Shared indications:
Fever
DICLOFENAC SODIUM
DICLOFENAC SODIUM
1 shared
Teva
Shared indications:
Arthritis
EPIOXA HD/EPIOXA KIT
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1 shared
GLAUKOS
Shared indications:
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HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
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1 shared
TRIS PHARMA INC
Shared indications:
Common Cold
KOVANAZE
OXYMETAZOLINE HYDROCHLORIDE
1 shared
ST RENATUS
Shared indications:
Common Cold
LANORINAL
ASPIRIN
1 shared
Novartis
Shared indications:
Headache
ORPHENGESIC
ASPIRIN
1 shared
GALT PHARMS
Shared indications:
Headache
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Fever
PROMETHAZINE DM
DEXTROMETHORPHAN HYDROBROMIDE
1 shared
PAI HOLDINGS
Shared indications:
Common Cold
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
1 shared
AMNEAL PHARMS
Shared indications:
Common Cold
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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.

NAPROXEN SODIUM 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

NAPROXEN SODIUM Patents & Exclusivity

Latest Patent: Mar 2026

Patents (8 active)

US10028925 Expires Mar 3, 2026
US10022344 Expires Mar 3, 2026
US11090280 Expires Mar 3, 2026
US9693979 Expires Mar 3, 2026
US9693978 Expires Mar 3, 2026
Source: FDA Orange Book

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Data Sources

FDA Approval: ANDA212199 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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