Drugs@FDA: FDA-Approved Drugs

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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
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 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.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-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-Proposal 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
07/29/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf

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