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Last Updated: March 28, 2024

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 six 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. Thirty-one 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
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 AUTHORIZED GENERIC Par Pharmaceutical, Inc. 0254-2008 0254-2008-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-01)
COLCRYS colchicine TABLET;ORAL 022352 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 0254-2008 0254-2008-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Jul 29, 2009TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING GOUT FLARES
Patent:⤷  Try a 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 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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