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Details for Generic Name: naproxen sodium

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Naproxen sodium is the generic ingredient in eight branded drugs marketed by Banner Life Sciences, Ohm Labs Inc, Almatica Pharma Inc, Actavis Labs Fl Inc, Bayer, Hoffmann La Roche, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Generics, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Marksans Pharma, Mylan, Perrigo, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, and Pernix Ireland Ltd, and is included in thirty-eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for naproxen sodium. Fifty-nine suppliers are listed for this compound.

Summary for Generic Name: naproxen sodium

Tradenames:8
Patents:5
Applicants:29
NDAs:38
Drug Master File Entries: see list42
Suppliers / Packaging: see list183
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

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

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

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

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

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

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Status: Completed Condition: Pain, Postoperative

Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
Status: Completed Condition: Migraine Disorders

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

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

Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Status: Completed Condition: Pain, Postoperative

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

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

Self Selection Trial of Naproxen Sodium
Status: Completed Condition: Pain

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

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Migraine

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Migraine, Acute

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

Naproxen Sodium ER Pharmacokinetic Study
Status: Completed Condition: Pain

Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Status: Completed Condition: Toothache

Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy
Status: Active, not recruiting Condition: Heterotopic Ossification

Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
Status: Completed Condition: Therapeutic Equivalence

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

Migraine Study in Adolescent Patients
Status: Completed Condition: Migraine Disorders

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Status: Completed Condition: Migraine Disorders; Migraine

Naproxen Sodium/ASA Platelet Study
Status: Completed Condition: Pain

Naproxen for Pain Control With Intrauterine Device Insertion
Status: Recruiting Condition: Contraception

Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Status: Completed Condition: Healthy

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
Status: Completed Condition: Healthy Volunteers

Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
Status: Completed Condition: Gastroduodenal Ulcer

A Randomized Controlled Trial of Oral Naproxen and Transdermal Estradiol for Bleeding in LNG-IUC
Status: Completed Condition: Contraception; Bleeding

Safety Trial of Naproxen Sodium/ Diphenhydramine
Status: Completed Condition: Pain

A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
Status: Completed Condition: Migraine Disorders

To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension
Status: Completed Condition: Osteoarthritis; Hypertension

Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
Status: Not yet recruiting Condition: Migraine; Headache

Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis
Status: Completed Condition: Pharyngitis

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
Status: Completed Condition: Migraine

To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects
Status: Completed Condition: Pharmacodynamic Interaction; Healthy Subjects

Phase I Study PK Study With OXP005 and Naprosyn
Status: Completed Condition: Pharmacokinetics

Postoperative Analgesia in Laminectomy
Status: Not yet recruiting Condition: Postoperative Pain; Postoperative Laminectomy Pain

Bunionectomy Study (0000-063)
Status: Completed Condition: Acute Pain

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Status: Completed Condition: Arthritis

Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
Status: Completed Condition: Osteoarthritis

Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine
Status: Not yet recruiting Condition: Migraine; Headache

Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Status: Completed Condition: Epicondylitis of the Elbow

Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy
Status: Completed Condition: Migraine Disorders

Single/Multiple Dose Bioavailability Trial
Status: Completed Condition: Healthy

Effectiveness of Theramine on Chronic Back Pain
Status: Completed Condition: Low Back Pain

Celecoxib Versus Naproxen for Prevention of Recurrent Ulcer Bleeding in Arthritis Patients
Status: Recruiting Condition: Arthritis; Cardiovascular Diseases; Cerebrovascular Disorders

Effect of Metamizole (Dipyrone) on Renal Function in Salt-depleted Healthy Subjects
Status: Completed Condition: Healthy

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
Status: Completed Condition: Migraine, Without Aura

A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure
Status: Completed Condition: Osteoarthritis; Hypertension

Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis
Status: Active, not recruiting Condition: Osteoarthritis

Treximet in the Treatment of Chronic Migraine
Status: Completed Condition: Chronic Migraine

Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
Status: Completed Condition: Arthritis

An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)
Status: Completed Condition: Dysmenorrhea

Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Status: Not yet recruiting Condition: Pain, Postoperative

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E
Status: Completed Condition: Healthy Volunteer

NOLAN: Naproxen or Loratadine and Neulasta
Status: Active, not recruiting Condition: Bone Pain in Stage I - III Breast Cancer

A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Status: Completed Condition: Arthritis, Juvenile Rheumatoid

A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
Status: Terminated Condition: Osteoarthritis, Knee

Naproxen Sodium Extended-Release Actual Use Study
Status: Completed Condition: Pain

Fast & Fed Pharmacokinetic (PK) Study
Status: Completed Condition: Bioavailability

A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee
Status: Completed Condition: Osteoarthritis, Hip; Osteoarthritis, Knee

Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Status: Completed Condition: Migraine; Tension-type Headache; Primary Headache Disorder

Efficacy of Sumatriptan With Naprosyn in Migraine With Aura
Status: Recruiting Condition: Migraine With Aura

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E
Status: Completed Condition: Healthy

Study of Naproxen Capsules to Treat Dental Pain
Status: Completed Condition: Dental Pain

A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
Status: Completed Condition: Spondylitis, Ankylosing

Derris Scandens Benth Extract VS Naproxen in Knee OA
Status: Completed Condition: Knee Osteoarthritis

A Study of Tanezumab in Adults With Chronic Low Back Pain
Status: Completed Condition: Low Back Pain

A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Status: Terminated Condition: Prostatic Neoplasms; Prostate Cancer

Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
Status: Completed Condition: Healthy

Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide
Status: Completed Condition: Renal Hemodynamics

TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders

The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
Status: Recruiting Condition: Pleural Effusion; Pleural Effusion Malignant

Effect of L-dopa In Subacute Back Pain Population
Status: Recruiting Condition: Sub-acute Back Pain

Copper IUD Treatment Observation Study
Status: Not yet recruiting Condition: Menorrhagia

An Open-label, Randomized, 3-period Crossover Study to Evaluate Sumatriptan Pharmacokinetics for a TREXIMA™ (Sumatriptan Succinate / Naproxen Sodium) Tablet Followed by IMITREX® (Sumatriptan Succinate)
Status: Completed Condition: Migraine With or Without Aura; Migraine Disorders; Cluster Headache; Migraine

Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex
Status: Completed Condition: Migraine

Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea
Status: Completed Condition: Migraine Disorders; Migraine

Changes in mRNA Expression Following Exposure to Naproxen
Status: Completed Condition: Healthy

A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
Status: Completed Condition: Healthy Volunteers; Bioequivalence

Naproxen on Tooth Sensitivity Caused by In-office Bleaching
Status: Active, not recruiting Condition: Toothache; Tooth Bleaching

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
Status: Active, not recruiting Condition: Arthritis, Rheumatoid

Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
Status: Completed Condition: Post-Vaginal Delivery Perineal Pain

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Status: Completed Condition: Ankylosing Spondylitis; Axial Spondyloarthritis

Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Status: Completed Condition: Migraine Disorders; Migraine

A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
Status: Completed Condition: Osteoarthritis

Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)
Status: Completed Condition: Rheumatoid Arthritis; Osteoarthritis

A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses.
Status: Completed Condition: Migraine Disorders; Migraine

Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis

Naproxen Versus Tramadol for Post Cesarean Pain Control
Status: Completed Condition: Pain; Cesarean Section

Efficacy of Co-administration of an NSAID With a Dopamine Agonist In Healthy Subjects
Status: Withdrawn Condition: Acute Pain

Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis

Variability in Response to Non-steroidal Anti-inflammatory Drugs
Status: Not yet recruiting Condition: Healthy

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Status: Completed Condition: Musculoskeletal Complications; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hamilton Pharms
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074106-002Aug 31, 1993DISCNNo<disabled><disabled>
Teva
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074142-001Dec 21, 1993DISCNNo<disabled><disabled>
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008RXYes8,022,095*PED<disabled>Y<disabled>
Hikma
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074480-002Feb 18, 1998RXNo<disabled><disabled>
Actavis Labs Fl Inc
NAPROXEN SODIUM
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL075416-002Apr 23, 2003RXNo<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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