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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021287
Company: CONCORDIA

Products on NDA 021287

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021287

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
05/22/2020	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021287s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021287Orig1s024ltr.pdf
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

Labels for NDA 021287

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

Therapeutic Equivalents for NDA 021287

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	079057	SUN PHARM
ALFUZOSIN HYDROCHLORIDE	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203192	UNICHEM
UROXATRAL	ALFUZOSIN HYDROCHLORIDE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021287	CONCORDIA

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