Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210895
Company: COSETTE

Products on NDA 210895

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WELCHOL	COLESEVELAM HYDROCHLORIDE	3.75GM	BAR, CHEWABLE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210895

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210895s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210895Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210895Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2020	SUPPL-1	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

Labels for NDA 210895

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022362s027,021776s047,210895s001lbl.pdf
04/03/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210895s000lbl.pdf