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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Harvard Business School
Queensland Health
US Army

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020254

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NDA 020254 describes VOLTAREN-XR, which is a drug marketed by Novartis and is included in one NDA. It is available from six suppliers. Additional details are available on the VOLTAREN-XR profile page.

The generic ingredient in VOLTAREN-XR is diclofenac sodium. There are forty-seven drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 020254
Ingredient:diclofenac sodium
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020254
Suppliers and Packaging for NDA: 020254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VOLTAREN-XR diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 020254 NDA AUTHORIZED GENERIC Sandoz Inc 0781-1381 N 0781-1381-01
VOLTAREN-XR diclofenac sodium TABLET, EXTENDED RELEASE;ORAL 020254 NDA AUTHORIZED GENERIC RxChange Co. 33358-451 E 33358-451-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 8, 1996TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Harvard Business School
Federal Trade Commission

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