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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021269
Company: VIATRIS

Products on NDA 021269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARDURA XL	DOXAZOSIN MESYLATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
CARDURA XL	DOXAZOSIN MESYLATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021269ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021269_carduraxl_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2021	SUPPL-21	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021269Orig1s021ltr.pdf
02/27/2017	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021269Orig1s018ltr.pdf
06/08/2015	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021269Orig1s17ltr.pdf
07/28/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/30/2012	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
07/08/2011	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021269s012ltr.pdf
03/16/2010	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021269s011ltr.pdf
03/24/2006	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021269s001ltr.pdf

Labels for NDA 021269

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/22/2021	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf
06/22/2021	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021269Orig1s021lbl.pdf
02/27/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021269s018lbl.pdf
06/08/2015	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021269s017lbl.pdf
07/08/2011	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021269s012lbl.pdf
03/16/2010	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021269s011lbl.pdf
02/22/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021269lbl.pdf

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