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Details for Generic Name: diclofenac sodium

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Summary for Generic Name: diclofenac sodium

Drug Master File Entries: see list46
Suppliers: see list19
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

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)

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Inc
diclofenac sodium
SOLUTION;TOPICAL204623Jan 16, 2014RXYes<disabled><disabled>
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074391Jun 29, 1995DISCNNo<disabled><disabled>
diclofenac sodium
SOLUTION;TOPICAL020947Nov 4, 2009RXYes8,546,450<disabled><disabled>
Mallinckrodt Inc
diclofenac sodium
SOLUTION;TOPICAL204623Jan 16, 2014RXYes8,741,956<disabled><disabled>
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL019201Jul 28, 1988DISCNNo<disabled><disabled>
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