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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022352
Company: TAKEDA PHARMS USA

Medication Guide

Summary Review

Products on NDA 022352

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLCRYS	COLCHICINE	0.6MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022352

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2009	ORIG-1	Approval	Type 7 - Drug Already Marketed without Approved NDA	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022352s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352_colcrys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022352s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2020	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022352Orig1s026ltr.pdf
12/22/2016	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
01/25/2016	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/17/2015	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022352Orig1s022ltr.pdf
11/25/2013	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
05/15/2013	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/14/2014	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022352Orig1s017ltr.pdf
07/20/2011	SUPPL-14	Labeling-Medication Guide, REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf
07/20/2011	SUPPL-13	REMS-Assessment	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022352s013s014ltr.pdf
04/29/2010	SUPPL-4	Labeling-Container/Carton Labels, REMS-Assessment, REMS-Modified, REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022352s004ltr.pdf

Labels for NDA 022352

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2020	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022352s026lbl.pdf
12/17/2015	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022352s022lbl.pdf
08/14/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022352s017lbl.pdf
07/20/2011	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf
07/20/2011	SUPPL-14	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf
07/20/2011	SUPPL-13	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf
04/29/2010	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf
04/29/2010	SUPPL-4	REMS-Assessment	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf
04/29/2010	SUPPL-4	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf
04/29/2010	SUPPL-4	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.pdf
07/29/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf

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