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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022352

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NDA 022352 describes COLCRYS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from four suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COLCRYS profile page.

The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 022352
Tradename:COLCRYS
Applicant:Takeda Pharms Usa
Ingredient:colchicine
Patents:17
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022352
Medical Subject Heading (MeSH) Categories for 022352
Suppliers and Packaging for NDA: 022352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLCRYS colchicine TABLET;ORAL 022352 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-854 N 43353-854-09
COLCRYS colchicine TABLET;ORAL 022352 NDA AUTHORIZED GENERIC American Health Packaging 60687-320 N 60687-320-21

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Jul 29, 2009TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING GOUT FLARES
Patent:➤ Try a Free TrialPatent Expiration:Dec 3, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:➤ Try a Free TrialPatent Expiration:Feb 17, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

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