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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 207233


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NDA 207233 describes VIVLODEX, which is a drug marketed by Iceutica Operations and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VIVLODEX profile page.

The generic ingredient in VIVLODEX is meloxicam. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 207233
Tradename:VIVLODEX
Applicant:Iceutica Operations
Ingredient:meloxicam
Patents:3
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 22, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 31, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 31, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF OSTEOARTHRITIS PAIN BY ADMINISTERING 10 MG OF MELOXICAM

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