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Details for Generic Name: diclofenac sodium

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Diclofenac sodium is the generic ingredient in seven branded drugs marketed by Tolmar, Fougera Pharms, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Mallinckrodt, Mallinckrodt Inc, Actavis Elizabeth, Carlsbad, Mylan Pharms Inc, Nostrum Labs, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Valeant Intl, Gd Searle Llc, Actavis Labs Fl Inc, and Eagle Pharms, and is included in thirty-six NDAs. There are fifteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fourty-six drug master file entries for diclofenac sodium. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:7
Patents:15
Applicants:27
NDAs:36
Drug Master File Entries: see list46
Suppliers: see list20
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents

Pharmacology for Ingredient: diclofenac sodium

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION;TOPICAL1.5%

Clinical Trials for: diclofenac sodium

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

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

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

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

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Status: Terminated Condition: Ankle Sprain

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

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
Roxane
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074391Jun 29, 1995DISCNNo<disabled><disabled>
Mallinckrodt
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL020947Nov 4, 2009RXYes8,217,078<disabled><disabled>
Mylan
DICLOFENAC SODIUM
diclofenac sodium
TABLET, EXTENDED RELEASE;ORAL076152Dec 13, 2001RXNo<disabled><disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,929,048<disabled><disabled>
Novartis
VOLTAREN
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201Jul 28, 1988DISCNNo<disabled><disabled>
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