Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022352
Company: TAKEDA PHARMS USA
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 |