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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, Paddock Llc, Taro, Watson Labs Inc, 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-nine NDAs. There are sixteen 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: diclofenac sodium

Drug Master File Entries: see list46
Suppliers: see list22
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
Paddock Llc
diclofenac sodium
SOLUTION;TOPICAL202393Nov 24, 2014RXNo<disabled><disabled>
Actavis Elizabeth
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074514Mar 26, 1996RXNo<disabled><disabled>
Fougera Pharms
diclofenac sodium
GEL;TOPICAL021005Oct 16, 2000RXYes5,792,753<disabled><disabled>
diclofenac sodium
SOLUTION;TOPICAL020947Nov 4, 2009RXYes8,741,956<disabled><disabled>
Mallinckrodt Inc
diclofenac sodium
SOLUTION;TOPICAL204623Jan 16, 2014RXYes8,618,164<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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