Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021176
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WELCHOL COLESEVELAM HYDROCHLORIDE 625MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/20/2021 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022362s029,021176s049lbl.pdf
07/29/2020 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s028,021176s048lbl.pdf
05/12/2020 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf
05/21/2019 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s045,022362s025lbl.pdf
01/16/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s044,022362s023lbl.pdf
01/22/2014 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf
06/28/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
06/28/2013 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
07/09/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf
01/03/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf
07/18/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf
09/14/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf
10/02/2009 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf
01/18/2008 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf
08/27/2007 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf
09/06/2006 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf
07/10/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf
11/17/2003 SUPPL-10 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf
10/10/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf
08/21/2003 SUPPL-8 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf
02/11/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf
10/17/2002 SUPPL-5 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf
05/26/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf

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