Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021287
Company: CONCORDIA PHARMS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2003 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21287_uroxatral_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_uroxatral_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2018 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021287s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021287Orig1s021ltr.pdf
03/23/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/21/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021287Orig1s018ltr.pdf
05/30/2013 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021287s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021287Orig1s017ltr.pdf
12/15/2010 SUPPL-16 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s016ltr.pdf
04/09/2010 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021287s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s014ltr.pdf
05/20/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021287s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021287s013ltr.pdf
09/18/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021287s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s011ltr.pdf
05/06/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s009ltr.pdf
03/29/2007 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021287s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021287s008ltr.pdf
11/16/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s007ltr.pdf
03/17/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021287s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s005ltr.pdf
07/15/2003 SUPPL-1 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21287slr001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021287_S001_UROXATRALTOC.cfml
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

UROXATRAL

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079013 APOTEX INC
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079060 AUROBINDO PHARMA LTD
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090284 INVAGEN PHARMS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079014 MYLAN
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079057 SUN PHARMA GLOBAL
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079056 TEVA PHARMS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 079054 TORRENT PHARMS
ALFUZOSIN HYDROCHLORIDE ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203192 UNICHEM LABS LTD
UROXATRAL ALFUZOSIN HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021287 CONCORDIA PHARMS INC

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