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Generated: November 18, 2018

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Details for New Drug Application (NDA): 207233

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NDA 207233 describes VIVLODEX, which is a drug marketed by Iroko Pharms Llc and is included in one NDA. It is available from one supplier. 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. Fifty-six suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Summary for 207233
Tradename:VIVLODEX
Applicant:Iroko Pharms Llc
Ingredient:meloxicam
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 207233
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Oct 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 22, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Mar 31, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 31, 2035Product Flag?YSubstance Flag?Delist Request?

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