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Last Updated: November 2, 2024

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. 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. One hundred and twenty-eight 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

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EXTENDED RELEASE;ORALStrength100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 8, 1996TE:RLD:Yes

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