Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021269
Company: PFIZER
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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