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Julphar
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Generated: April 21, 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 four 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. Seventy suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.
Summary for 020254
Tradename:VOLTAREN-XR
Applicant:Novartis
Ingredient:diclofenac sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
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 PD-Rx Pharmaceuticals, Inc. 43063-543 N 43063-543-60

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EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Chinese Patent Office
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US Department of Justice
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