Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022362
Company: DAIICHI SANKYO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WELCHOL COLESEVELAM HYDROCHLORIDE 1.875GM/PACKET FOR SUSPENSION;ORAL Discontinued None Yes No
WELCHOL COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;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
10/02/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021176s022_022362s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362_welchol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022362s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s045,022362s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021176Orig1s045, 022362Orig1s025ltr.pdf
04/10/2019 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022362Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022362Orig1s024ltr.pdf
01/16/2019 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s044,022362s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/21176Orig1s044,022362Orig1s023ltr.pdf
01/22/2014 SUPPL-20 Labeling-Package Insert 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
03/11/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-18 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
06/28/2013 SUPPL-17 Labeling-Container/Carton Labels, 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
03/07/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/28/2013 SUPPL-15 Labeling-Container/Carton Labels, 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
02/27/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/15/2012 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/09/2012 SUPPL-10 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-9 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-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022362s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022362s007,021176s028ltr.pdf
09/14/2010 SUPPL-2 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/21/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s045,022362s025lbl.pdf
04/10/2019 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022362Orig1s024lbl.pdf
01/16/2019 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021176s044,022362s023lbl.pdf
01/22/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021176s037,022362s020lbl.pdf
06/28/2013 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
06/28/2013 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
06/28/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
06/28/2013 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
06/28/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021176s034s038,022362s015s017s018lbl.pdf
07/09/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s030,022362s010lbl.pdf
01/03/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021176s029,022362s009lbl.pdf
07/18/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022362s007lbl.pdf
09/14/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021176s027,022362s002lbl.pdf
10/02/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022362lbl.pdf

WELCHOL

FOR SUSPENSION;ORAL; 3.75GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 210316 ALKEM LABS LTD
COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 202190 GLENMARK PHARMS LTD
WELCHOL COLESEVELAM HYDROCHLORIDE 3.75GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022362 DAIICHI SANKYO

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