Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021287
Company: CONCORDIA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UROXATRAL ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/22/2020 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021287s024lbl.pdf
05/14/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021287s021lbl.pdf
04/21/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf
05/30/2013 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf
12/15/2010 SUPPL-16 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf
04/09/2010 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf
05/20/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf
09/18/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf
03/29/2007 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf
11/16/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf
03/17/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf
06/12/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf

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