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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 22362

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WELCHOL	COLESEVELAM HYDROCHLORIDE	1.875GM/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION;ORAL	Discontinued	None	Yes	No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

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-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
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

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