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Profile for Tradename: NAPRELAN

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Naprelan is a drug marketed by Alvogen Malta and is included in one NDA. It is available from ten suppliers.

The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.

Summary for Tradename: NAPRELAN

Suppliers / Packagers: see list24

Pharmacology for Tradename: NAPRELAN

Clinical Trials for: NAPRELAN

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: Lynch Syndrome

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

Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal
Status: Recruiting Condition: Pain; Other Surgical Procedures; Impacted Third Molar Tooth

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

Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
Status: Recruiting Condition: Osteoarthritis, Knee

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
Status: Completed Condition: Gastric Ulcer

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
Status: Completed Condition: Gastric Ulcer

Naproxen for the Prevention of HO After Complex Elbow Trauma
Status: Withdrawn Condition: Heterotopic Ossification

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen Malta
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 1996RXNo<disabled><disabled>
Alvogen Malta
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-002Jan 5, 1996RXNo<disabled><disabled>
Alvogen Malta
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-003Jan 5, 1996RXYes<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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