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Last Updated: February 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207233


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NDA 207233 describes VIVLODEX, which is a drug marketed by Zyla and is included in one NDA. It is available from two suppliers. 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-one suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 207233
Tradename:VIVLODEX
Applicant:Zyla
Ingredient:meloxicam
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 207233
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 207233
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIVLODEX meloxicam CAPSULE;ORAL 207233 NDA Iroko Pharmaceuticals, LLC 42211-205 42211-205-23 30 CAPSULE in 1 BOTTLE (42211-205-23)
VIVLODEX meloxicam CAPSULE;ORAL 207233 NDA Iroko Pharmaceuticals, LLC 42211-205 42211-205-29 90 CAPSULE in 1 BOTTLE (42211-205-29)
Paragraph IV (Patent) Challenges for 207233
Tradename Dosage Ingredient NDA Submissiondate
VIVLODEX CAPSULE;ORAL meloxicam 207233 2017-01-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Oct 22, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 31, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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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