Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022352
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLCRYS COLCHICINE 0.6MG TABLET;ORAL Prescription AB Yes Yes
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
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 REMS-Modified, Labeling-Container/Carton Labels, REMS-Assessment, 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022352s004lbl.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-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

COLCRYS

TABLET;ORAL; 0.6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 211250 ALKEM LABS LTD
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 204711 AMNEAL PHARMS
COLCHICINE COLCHICINE 0.6MG TABLET;ORAL Prescription No AB 211519 ZYDUS PHARMS
COLCRYS COLCHICINE 0.6MG TABLET;ORAL Prescription Yes AB 022352 TAKEDA PHARMS USA

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