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Medicines · US (FDA)
NSAIDs

FDA 1995

Propionic acid derivatives

Naproxen

Approved 10 Feb 1995OralTablet

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: NAPROXEN 250MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

NAPROXEN 25MG/ML · SuspensionANDA211910-001 · Prescription
NAPROXEN 500MG · TabletANDA074121-003 · Discontinued
NAPROXEN 250MG · TabletANDA074121-001 · Discontinued
NAPROXEN 375MG · TabletANDA074121-002 · Discontinued
NAPROXEN 500MG · TabletANDA074129-003 · Discontinued
NAPROXEN 250MG · TabletANDA074129-001 · Discontinued
NAPROXEN 375MG · TabletANDA074129-002 · Discontinued
NAPROXEN 375MG · TabletANDA074163-002 · Discontinued
NAPROXEN 500MG · TabletANDA074163-003 · Discontinued
NAPROXEN 250MG · TabletThis page
NAPROXEN 25MG/ML · SuspensionANDA215776-001 · Prescription
NAPROXEN 375MG · Tablet, delayed releaseANDA218497-001 · Prescription
NAPROXEN 500MG · Tablet, delayed release

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ANDA218497-002 · Prescription

NAPROXEN 375MG · TabletANDA074211-002 · Discontinued

NAPROXEN 500MG · TabletANDA074211-003 · Discontinued

NAPROXEN 250MG · TabletANDA074211-001 · Discontinued

NAPROXEN 375MG · TabletANDA074263-002 · Discontinued

NAPROXEN 500MG · TabletANDA074263-003 · Discontinued

NAPROXEN 250MG · TabletANDA074263-001 · Discontinued

NAPROXEN 500MG · TabletANDA074457-003 · Discontinued

NAPROXEN 250MG · TabletANDA074457-001 · Discontinued

NAPROXEN 375MG · TabletANDA074457-002 · Discontinued

NAPROXEN 375MG · TabletANDA075927-002 · Prescription

NAPROXEN 500MG · TabletANDA075927-003 · Prescription

NAPROXEN 250MG · TabletANDA075927-001 · Prescription

NAPROXEN 375MG · TabletANDA076494-002 · Discontinued

NAPROXEN 500MG · TabletANDA076494-003 · Discontinued

NAPROXEN 250MG · TabletANDA076494-001 · Discontinued

NAPROXEN 375MG · TabletANDA091305-002 · Discontinued

NAPROXEN 500MG · TabletANDA091305-003 · Discontinued

NAPROXEN 250MG · TabletANDA091305-001 · Discontinued

NAPROXEN 375MG · TabletANDA091416-002 · Prescription

NAPROXEN 500MG · TabletANDA091416-003 · Prescription

NAPROXEN 250MG · TabletANDA091416-001 · Prescription

NAPROXEN 25MG/ML · SuspensionANDA212705-001 · Prescription

NAPROXEN 500MG · Tablet, delayed releaseANDA216908-002 · Prescription

NAPROXEN 375MG · Tablet, delayed releaseANDA216908-001 · Prescription

NAPROXEN 500MG · TabletANDA077339-003 · Discontinued

NAPROXEN 250MG · TabletANDA077339-001 · Discontinued

NAPROXEN 375MG · TabletANDA077339-002 · Discontinued

NAPROXEN 375MG · Tablet, delayed releaseANDA091432-001 · Prescription

NAPROXEN 500MG · Tablet, delayed releaseANDA091432-002 · Prescription

NAPROXEN 375MG · TabletANDA074111-002 · Discontinued

NAPROXEN 500MG · TabletANDA074111-003 · Discontinued

NAPROXEN 250MG · TabletANDA074111-001 · Discontinued

NAPROXEN 500MG · TabletANDA074105-003 · Discontinued

NAPROXEN 250MG · TabletANDA074105-001 · Discontinued

NAPROXEN 375MG · TabletANDA074105-002 · Discontinued

NAPROXEN 375MG · TabletANDA074182-002 · Discontinued

NAPROXEN 500MG · TabletANDA074182-003 · Discontinued

NAPROXEN 250MG · TabletANDA074182-001 · Discontinued

NAPROXEN 500MG · TabletANDA074216-003 · Discontinued

NAPROXEN 250MG · TabletANDA074216-001 · Discontinued

NAPROXEN 375MG · TabletANDA074216-002 · Discontinued

NAPROXEN 500MG · Tablet, delayed releaseANDA075227-002 · Prescription

NAPROXEN 375MG · Tablet, delayed releaseANDA075227-001 · Prescription

NAPROXEN 500MG · TabletANDA212517-003 · Prescription

NAPROXEN 250MG · TabletANDA212517-001 · Prescription

NAPROXEN 375MG · TabletANDA212517-002 · Prescription

NAPROXEN 500MG · TabletANDA074201-003 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA074163.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Naproxen
Drug class: Propionic acid derivatives, Antiinflammatory products for vaginal administration
Group: NSAIDs
Route: Oral
Dosage form: Tablet
Applicant: Watson Labs Teva
Status: Discontinued
FDA approval: 10 Feb 1995
Application: ANDA074163-001
RxCUI: 7258

Guidelines

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FDA 2020MeloxicamCapsule

FDA 2020Advil Dual Action with Acetaminophenacetaminophen · Tablet

FDA 2018Licartdiclofenac epolamine · System

FDA 2018Naproxen Sodium and Diphenhydramine Hydrochloridediphenhydramine hydrochloride · Tablet

FDA 2018Naproxen and Esomeprazole Magnesiumesomeprazole magnesium · Tablet, delayed release

FDA 2018Consensiamlodipine besylate · Tablet

FDA 2018Sumatriptan and Naproxen Sodiumnaproxen sodium · Tablet

FDA 2017Ibuprofen and Pseudoephedrine Hydrochlorideibuprofen · Capsule

FDA 2016DiclofenacCapsule

FDA 2016Diclofenac PotassiumFor solution

FDA 2016Ibuprofen LysineInjectable