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Details for Generic Name: diclofenac sodium

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Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Tolmar, Fougera Pharms, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Javelin Pharms Inc, Paddock Llc, Taro, Watson Labs Inc, Horizon Pharma, Nuvo Res 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 fourty NDAs. There are fourteen 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-three 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 list23
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

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: Completed Condition: Pain

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

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Status: Completed Condition: Multiple Sclerosis

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074376-002Sep 28, 1995RXYes<disabled><disabled>
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074391-002Jun 29, 1995DISCNNo<disabled><disabled>
Apotex Inc
diclofenac sodium
SOLUTION;TOPICAL202027-001May 27, 2014RXNo<disabled><disabled>
Actavis Elizabeth
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074514-001Mar 26, 1996RXNo<disabled><disabled>
Actavis Labs Fl Inc
diclofenac sodium; misoprostol
TABLET, DELAYED RELEASE;ORAL201089-002Jul 9, 2012RXNo<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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