alfuzosin Extended Release Oral Tablet

Brand(s)
UroXatral
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Covis Pharmaceuticals, Inc. (2013-09-25)
Oldest Current Product
2004-06-22
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ALFUZOSIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ALFUZOSIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\ALFUZOSIN HYDROCHLORIDE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ALFUZOSIN HYDROCHLORIDE
ORAL\TABLET\ALFUZOSIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ALFUZOSIN
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\ALFUZOSIN
ORAL\TABLET\ALFUZOSIN

product(s) by strength(s)

24 hr alfuzosin hydrochloride 10 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000244200UroXatralNDASanofi-Aventis U.S. Llc2009-06-05ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA021287df3c1900-a076-4a3a-a2a8-5939d818451f
2249870200UroXatralNDACovis Pharmaceuticals, Inc.2013-06-03ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASENDA0212870b845270-129e-4624-aeff-10eb77cc6984

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003785005ANDAMylan Pharmaceuticals Inc.2011-08-09ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA079014be485a4c-aba3-43fa-9904-403595bc3f96
2136680021ANDATorrent Pharmaceuticals Limited2011-07-18ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA0790546220496a-b651-4e7b-9a41-0ea949de3df0
3317220302ANDACamber Pharmaceuticals, Inc.2012-01-18ALFUZOSIN HYDROCHLORIDEORALTABLETANDA0902848704702e-0889-4a47-9a92-588a8d72d503
4473350956ANDASun Pharma Global Fze2011-11-22ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA079057d2af616e-673a-4fdd-ace8-db2d0f154604
5572370114ANDACitron Pharma Llc2012-08-30ALFUZOSIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA07906043675e9d-a361-4109-9ae1-54d80580fbbd
6605052850ANDAApotex Corp2011-07-18ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA07901326fcc267-c8d7-e059-1bcf-830dded43690
7658620249ANDAAurobindo Pharma Limited2012-08-30ALFUZOSIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASEANDA079060d163369b-e44b-4591-b166-7ddd0c1c13c0
8762820302ANDAExelan Pharmaceuticals Inc.2012-10-02ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASEANDA090284f075a897-7bef-4799-b7e2-7e051c461443

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1556480738ANDAWockhardt Limited2012-08-15ALFUZOSIN HYDROCHLORIDEORALTABLETANDA09022130f97b8e-4486-4b5f-896a-d7dfa1e2e33a
2646790738ANDAWockhardt Usa Llc.2012-08-15ALFUZOSIN HYDROCHLORIDEORALTABLETANDA090221f861c40a-504b-42c0-a17d-af35c0f187f9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900279UroXatralNDAStat Rx Usa Llc2009-06-05ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE000244200NDA0212870fb9f3ab-45d1-405e-a14e-4cb4b1a28c55
2332610994ANDAAidarex Pharmaceuticals Llc2011-11-22ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE473350956ANDA07905794458f26-9269-4fbc-80db-adc43b1fc62f
3422910110ANDAAvkare, Inc.2012-03-13ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE605052850ANDA0790132d4f6e4f-e385-b872-38c6-b7d1a9e8f9b9
4548685046UroXatralNDAPhysicians Total Care, Inc.2004-06-22ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE000244200NDA0212871c5502c7-7731-4d3e-b4fe-7fd44dd5908b
5548686329ANDAPhysicians Total Care, Inc.2012-02-22ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE605052850ANDA0790130feb7a22-7416-4502-bf6e-6341782d11ab
6604290347ANDAGolden State Medical Supply, Inc.2011-07-18ALFUZOSIN HYDROCHLORIDEORALTABLET, EXTENDED RELEASE605052850ANDA07901323ba1d84-686f-41f6-ac83-8d839ae25350

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA079013ALFUZOSIN HYDROCHLORIDEAPOTEX INC2011-07-18ANDA079013_001
2ANDA079014ALFUZOSIN HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2011-07-18ANDA079014_001
3ANDA079054ALFUZOSIN HYDROCHLORIDETORRENT PHARMACEUTICALS LTD.2011-07-18ANDA079054_001
4ANDA079056ALFUZOSIN HYDROCHLORIDETEVA PHARMACEUTICALS USA2011-07-18ANDA079056_001
5ANDA079057ALFUZOSIN HYDROCHLORIDESUN PHARMA GLOBAL INC2011-07-18ANDA079057_001
6ANDA079060ALFUZOSIN HYDROCHLORIDEAUROBINDO PHARMA LTD2012-08-30ANDA079060_001
7ANDA090221ALFUZOSIN HYDROCHLORIDETrueWOCKHARDT LTD2012-08-10ANDA090221_001
8ANDA090284ALFUZOSIN HYDROCHLORIDEINVAGEN PHARMACEUTICALS INC2012-01-17ANDA090284_001
9NDA021287UROXATRALCONCORDIA PHARMACEUTICALS INC2003-06-12p6149940NDA021287_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA079013_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-07-18ALFUZOSIN HYDROCHLORIDE
2ANDA079014_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-07-18ALFUZOSIN HYDROCHLORIDE
3ANDA079054_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-07-18ALFUZOSIN HYDROCHLORIDE
4ANDA079056_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-07-18ALFUZOSIN HYDROCHLORIDE
5ANDA079057_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2011-07-18ALFUZOSIN HYDROCHLORIDE
6ANDA079060_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-08-30ALFUZOSIN HYDROCHLORIDE
7ANDA090221_001discontinuedALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalse2012-08-10ALFUZOSIN HYDROCHLORIDE
8ANDA090284_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-01-17ALFUZOSIN HYDROCHLORIDE
9NDA021287_001RXALFUZOSIN HYDROCHLORIDE (10MG)ORALTABLET, EXTENDED RELEASETrueAB2003-06-12UROXATRAL

patent(s)

#idexpiration dateapplication(s)
1p6149940 (view patent)2017-08-22NDA021287

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b845270-129e-4624-aeff-10eb77cc6984 (view SPL)These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionCovis Pharmaceuticals, Inc.2013-09-252249870200
20fb9f3ab-45d1-405e-a14e-4cb4b1a28c55 (view SPL)UROXATRAL (alfuzosin hydrochloride) tablet, extended releaseprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-272165900279
30feb7a22-7416-4502-bf6e-6341782d11ab (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets.Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-053548686329
41c5502c7-7731-4d3e-b4fe-7fd44dd5908b (view SPL)These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-08-301548685046
523ba1d84-686f-41f6-ac83-8d839ae25350 (view SPL)Alfuzosin Hydrochloride Extended-Release Tablets, USP Initial U.S. Approval: 2003 These highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets.prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-092604290347
626fcc267-c8d7-e059-1bcf-830dded43690 (view SPL)These highlights do not include all the information needed to use ALFUZOSIN hydrochloride extended-release tablets safely and effectively. See full prescribing information for ALFUZOSIN hydrochloride extended-release tablets. ALFUZOSIN Hydrochloride Extended-Release Tablets, USP for Oral Use Initial U.S. Approval: 2003prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-06-269605052850
72d4f6e4f-e385-b872-38c6-b7d1a9e8f9b9 (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets.Alfuzosin Hydrochloride Extended-Release Tablets, USP for Oral UseInitial U.S. Approval: 2003prescriptionHuman PrescriptionAvkare, Inc.2015-01-056422910110
830f97b8e-4486-4b5f-896a-d7dfa1e2e33a (view SPL)These highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2012-07-201556480738
943675e9d-a361-4109-9ae1-54d80580fbbd (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended release tablets.ALFUZOSIN Hydrochloride Extended Release Tablets, for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionCitron Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-09-191572370114
106220496a-b651-4e7b-9a41-0ea949de3df0 (view SPL)These highlights do not include all the information needed to usealfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets.Alfuzosin Hydrochloride Extended-release Tablets USP,for oral use Initial U.S. Approval: 2003prescriptionHuman PrescriptionTorrent Pharmaceuticals LimitedManufacture2014-06-246136680021
118704702e-0889-4a47-9a92-588a8d72d503 (view SPL)These highlights do not include all the information needed to use Alfuzosin Hydrochloride safely and effectively. See full prescribing information for Alfuzosin Hydrochloride. Alfuzosin Hydrochloride (Alfuzosin Hydrochloride) TABLET for ORAL use.Initial U.S. Approval: 2003prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.MANUFACTURE2012-01-181317220302
1294458f26-9269-4fbc-80db-adc43b1fc62f (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. Alfuzosin Hydrochloride Extended-Release TabletsInitial U.S. Approval: 2003prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-142332610994
139fc7f119-f36b-44cf-945d-940160f3afe3 (view SPL)These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionConcordia Pharmaceuticals Inc.2015-08-311592120200
14be485a4c-aba3-43fa-9904-403595bc3f96 (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride extended-release tablets safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets.ALFUZOSIN hydrochloride extended-release tablets, USP for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-06-247003785005
15d163369b-e44b-4591-b166-7ddd0c1c13c0 (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended release tablets.ALFUZOSIN hydrochloride extended release tablets, for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-09-227658620249
16d2af616e-673a-4fdd-ace8-db2d0f154604 (view SPL)These highlights do not include all the information needed to use ALFUZOSIN HYDROCHLORIDE safely and effectively. See full prescribing information for ALFUZOSIN HYDROCHLORIDE extended-release tablets.ALFUZOSIN HYDROCHLORIDE extended-release tablets, for oral useInitial U.S. Approval: 2003prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-058473350956
17df3c1900-a076-4a3a-a2a8-5939d818451f (view SPL)These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2012-08-0115000244200
18f075a897-7bef-4799-b7e2-7e051c461443 (view SPL)These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionExelan Pharmaceuticals Inc.2014-04-172762820302
19f861c40a-504b-42c0-a17d-af35c0f187f9 (view SPL)These highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003prescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-07-202646790738

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII