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Profile for Tradename: SOLARAZE

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Solaraze is a drug marketed by Fougera Pharms and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SOLARAZE is diclofenac sodium. There are fourty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the diclofenac sodium profile page.

Summary for Tradename: SOLARAZE

Patents:6
Applicants:1
NDAs:1
Suppliers: see list2

Pharmacology for Tradename: SOLARAZE

Clinical Trials for: SOLARAZE

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
Status: Completed Condition: Pain

Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
Status: Completed Condition: Photosensitivity Disorders

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Status: Not yet recruiting Condition: Inflammation; Pain

Effects of Pennsaid on Clinical Neuropathic Pain
Status: Active, not recruiting Condition: Neuralgia; Postherpetic Neuralgia; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Status: Completed Condition: Ankle Sprain

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
Status: Completed Condition: Primary Dysmenorrhea

Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
Status: Recruiting Condition: Athletic Injuries

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
Status: Not yet recruiting Condition: Rheumatoid Arthritis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,639,738<disabled><disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,792,753<disabled><disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,985,850<disabled>Y<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,914,322<disabled><disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,852,002<disabled><disabled>
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Paragraph IV activity for: SOLARAZE

Drugname Dosage Strength RLD Submissiondate
diclofenac sodiumTopical Gel3%Solaraze12/16/2009
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ISSN: 2162-2639

Preferred citation:

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

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