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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204768

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NDA 204768 describes TIVORBEX, 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. Additional details are available on the TIVORBEX profile page.

The generic ingredient in TIVORBEX is indomethacin. There are fifteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the indomethacin profile page.
Summary for 204768
Tradename:TIVORBEX
Applicant:Iroko Pharms Llc
Ingredient:indomethacin
Patents:3
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 204768
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVORBEX indomethacin CAPSULE;ORAL 204768 NDA Iroko Pharmaceuticals, LLC 42211-201 N 42211-201-23
TIVORBEX indomethacin CAPSULE;ORAL 204768 NDA Iroko Pharmaceuticals, LLC 42211-201 N 42211-201-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Feb 24, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 23, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN

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