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 | Discontinued | None | Yes | No |
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-Proposal, REMS-Assessment, REMS-Modified |
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 |
---|---|---|---|---|---|
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-Proposal | 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 | |
07/29/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022352lbl.pdf |