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Details for Generic Name: naproxen sodium

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Summary for Generic Name: naproxen sodium

Drug Master File Entries: see list42
Suppliers: see list46
Therapeutic Class:Analgesics
Anti-inflammatory Agents

Pharmacology for Ingredient: naproxen sodium

Clinical Trials for: naproxen sodium

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-month Period
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Migraine, Acute; Migraine Headaches

Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Healthy

Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
Status: Completed Condition: Pain, Postoperative

Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan
Status: Completed Condition: Pharmacokinetics

Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome
Status: Recruiting Condition: Precancerous Condition

Naproxen Codeine in Arthroscopic Surgery
Status: Completed Condition: Arthroscopic Meniscus Surgery

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
Status: Completed Condition: Healthy

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Status: Completed Condition: Sleep

A Pharmacokinetic (PK) Study Evaluating Naproxen and Esomeprazole Plasma Levels
Status: Completed Condition: Arthritis

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
naproxen sodium
TABLET;ORAL018164Sep 30, 1987RXYes<disabled><disabled>
naproxen sodium
TABLET;ORAL074367Aug 31, 1994DISCNNo<disabled><disabled>
Watson Labs
naproxen sodium
TABLET;ORAL074195Dec 21, 1993DISCNNo<disabled><disabled>
naproxen sodium
TABLET;ORAL074257Dec 21, 1993DISCNNo<disabled><disabled>
naproxen sodium; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL076518Mar 17, 2004OTCNo<disabled><disabled>
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