Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/26/2000 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-141_Welchol.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

05/20/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf
01/22/2014 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021176Orig1s037,022362Orig1s020ltr.pdf
02/25/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/22/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021176Orig1s034,s038,022362Orig1s015,s017,s018ltr_replace.pdf
07/09/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176Orig1s030,022362Orig1s010ltr.pdf
01/03/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021176s029,022362s009ltr.pdf
07/18/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021176s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf
09/14/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021176s027,022362s002ltr.pdf
10/02/2009 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf
05/30/2008 SUPPL-21 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s021ltr.pdf
08/27/2007 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021176s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021176s019ltr.pdf
01/18/2008 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021176s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021176s017ltr.pdf
07/10/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s015LTR.pdf
09/06/2006 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021176s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021176s014_ltr.pdf
11/17/2003 SUPPL-10 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs010_welchol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs010ltr.pdf
10/10/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176slr009_welChol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr009ltr.pdf
08/21/2003 SUPPL-8 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21176scs008_welchol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176scs008ltr.pdf
08/08/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2002 SUPPL-5 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21176s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21176scp005ltr.pdf
02/11/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021176s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21176slr004ltr.pdf
05/10/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/2001 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

WELCHOL

TABLET;ORAL; 625MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 625MG TABLET;ORAL Prescription No AB 203480 GLENMARK PHARMS LTD
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 625MG TABLET;ORAL Prescription No AB 091600 IMPAX LABS INC
WELCHOL COLESEVELAM HYDROCHLORIDE 625MG TABLET;ORAL Prescription Yes AB 021176 DAIICHI SANKYO

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