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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022362
Company: COSETTE

Summary Review

Products on NDA 022362

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WELCHOL	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No
WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022362

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
10/20/2021	SUPPL-29	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022362s029,021176s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022362Orig1s029,021176Orig1s049ltr.pdf
07/29/2020	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s028,021176s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022362Orig1s028, 021176Orig1s048ltr.pdf
05/12/2020	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022362Orig1s027,021176Orig1s047,210895Orig1s001ltr.pdf
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

Labels for NDA 022362

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/20/2021	SUPPL-29	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022362s029,021176s049lbl.pdf
07/29/2020	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s028,021176s048lbl.pdf
05/12/2020	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf
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

Therapeutic Equivalents for NDA 022362

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
COLESEVELAM HYDROCHLORIDE	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	212886	IMPAX
WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM/PACKET	FOR SUSPENSION;ORAL	Prescription	Yes	AB	022362	COSETTE

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