bicalutamide Oral Tablet

Brand(s)
Casodex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-02-27)
Oldest Current Product
1995-10-16
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BICALUTAMIDE
FDAOB
ORAL\TABLET\BICALUTAMIDE
SPL Active
ORAL\TABLET, FILM COATED\BICALUTAMIDE
ORAL\TABLET\BICALUTAMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\BICALUTAMIDE
ORAL\TABLET\BICALUTAMIDE

product(s) by strength(s)

bicalutamide 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100705CasodexNDAAstrazeneca Pharmaceuticals Lp1995-10-16BICALUTAMIDEORALTABLETNDA02049803607c0d-b772-435f-c985-ecce8ea8cafd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930220ANDATeva Pharmaceuticals Usa Inc2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA07693289c24844-4d2a-4ec6-bc28-adce7b82d0c0
2003787017ANDAMylan Pharmaceuticals Inc.2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA0791850c3b8420-01ec-4a4a-97a2-222884522963
3007815409ANDASandoz Inc2009-07-06BICALUTAMIDEORALTABLETANDA078575f32eadf6-d515-4307-a722-c49f0f1aef61
4009046019ANDAMajor2010-05-11BICALUTAMIDEORALTABLETANDA07891782d4877e-6ebf-4f75-a108-28dc840b07fc
5167140571ANDANorthstar Rx Llc2009-08-28BICALUTAMIDEORALTABLET, FILM COATEDANDA078634f03d7e7a-cbe9-4788-894c-d30739f7e733
6167290023ANDAAccord Healthcare Inc.2009-07-06BICALUTAMIDEORALTABLETANDA0789177c295b64-ec39-42ec-9f02-da5b42e775e1
7416160485ANDASun Pharma Global Inc.2009-07-07BICALUTAMIDEORALTABLETANDA079110427a872b-1b0b-41cf-aca2-49ce0163c7e6
8473350485ANDASun Pharma Global Fze2014-12-15BICALUTAMIDEORALTABLET, FILM COATEDANDA0791108b533fe4-287f-482c-b530-d9a5bf2ce40c
9605052642ANDAApotex Corp2009-07-06BICALUTAMIDEORALTABLETANDA0789177cd5fd99-ea7f-432d-aa05-8c0ab4fffb75
10658410613ANDACadila Healthcare Limited2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA0790898e26fbf0-511c-44d9-b484-372d7b50b55e
11683820224ANDAZydus Pharmaceuticals (Usa) Inc.2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA079089d0348cf0-f79a-4579-86c9-a5d25d688659

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1519910560ANDABreckenridge Pharmaceutical, Inc.2010-11-16BICALUTAMIDEORALTABLET, FILM COATEDANDA0779734db9bad7-6256-4473-ac48-9e56c4a24d51
2604290226ANDAGolden State Medical Supply, Inc.2010-11-16BICALUTAMIDEORALTABLET, FILM COATED519910560ANDA077973abaf380b-7434-426a-934b-73f6f094c82e
3636720005ANDASynthon Pharmaceuticals, Inc.2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA077973c267f783-1d39-4f27-83ed-8288577bf66d
4672530191ANDADava Pharmaceuticals, Inc.2009-07-06BICALUTAMIDEORALTABLET, FILM COATEDANDA07797359df7b06-81d0-423c-9e80-9014d424b64c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910168ANDAAvkare, Inc.2014-01-13BICALUTAMIDEORALTABLET, FILM COATED000930220ANDA0769327bd07bdf-2742-c2f6-6314-bd175240b95f
2521250709ANDARemedyrepack Inc.2013-09-19BICALUTAMIDEORALTABLET167290023ANDA078917487ef40e-abb2-4107-b9e9-819e10c27321
3548684503CasodexNDAPhysicians Total Care, Inc.2002-06-04BICALUTAMIDEORALTABLET003100705NDA0204985bd7e54e-8497-4bc4-8964-151943db0626
4548686133ANDAPhysicians Total Care, Inc.2010-08-09BICALUTAMIDEORALTABLET, FILM COATED000930220ANDA076932020d34eb-9560-4218-9d87-dfdeff705c3a
5604290177ANDAGolden State Medical Supply, Inc.2014-05-08BICALUTAMIDEORALTABLET, FILM COATED167290023ANDA0789177c9a8877-7364-4a3c-9345-78279fa282eb
6636295321ANDABryant Ranch Prepack2009-07-06BICALUTAMIDEORALTABLET167290023ANDA078917175218a9-2795-4938-aeea-95750dc8b77c
7680840612ANDAAmerican Health Packaging2012-11-292016-09-30BICALUTAMIDEORALTABLET416160485ANDA079110aeb2641f-4842-43ff-a4d8-d01b4ab3f47b
8691890298ANDAAvera Mckennan Hospital2015-03-01BICALUTAMIDEORALTABLET, FILM COATED000930220ANDA076932c56d2445-ba72-4ce8-a4a4-1a9701f7d344

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA076932BICALUTAMIDETEVA PHARMACEUTICALS USA INC2009-07-06ANDA076932_001Amlodipine Oral Tablet
2ANDA077973BICALUTAMIDETrueSYNTHON PHARMACEUTICALS INC2009-07-06ANDA077973_001Amlodipine Oral Tablet
3ANDA077995BICALUTAMIDETrueKUDCO IRELAND LTD2009-07-06ANDA077995_001Amlodipine Oral Tablet
4ANDA078285BICALUTAMIDETrueROXANE LABORATORIES INC2011-03-24ANDA078285_001Amlodipine Oral Tablet
5ANDA078575BICALUTAMIDESANDOZ INC2009-07-06ANDA078575_001Amlodipine Oral Tablet
6ANDA078634BICALUTAMIDEACTAVIS TOTOWA LLC2009-08-28ANDA078634_001Amlodipine Oral Tablet
7ANDA078917BICALUTAMIDEACCORD HEALTHCARE INC2009-07-06ANDA078917_001Amlodipine Oral Tablet
8ANDA079045BICALUTAMIDEFRESENIUS KABI ONCOLOGY PLC2010-05-13ANDA079045_001Amlodipine Oral Tablet
9ANDA079089BICALUTAMIDEZYDUS PHARMACEUTICALS USA INC2009-07-06ANDA079089_001Amlodipine Oral Tablet
10ANDA079110BICALUTAMIDESUN PHARMA GLOBAL INC2009-07-06ANDA079110_001Amlodipine Oral Tablet
11ANDA079185BICALUTAMIDEMYLAN PHARMACEUTICALS INC2009-07-06ANDA079185_001Amlodipine Oral Tablet
12ANDA091011BICALUTAMIDESTASON PHARMACEUTICALS INC2015-06-10ANDA091011_001Amlodipine Oral Tablet
13ANDA200274BICALUTAMIDEAPOTEX INC2015-05-21ANDA200274_001Amlodipine Oral Tablet
14NDA020498CASODEXASTRAZENECA UK LTD1995-10-04NDA020498_001Amlodipine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076932_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
2ANDA077973_001discontinuedBICALUTAMIDE (50MG)ORALTABLETFalse2009-07-06BICALUTAMIDE
3ANDA077995_001discontinuedBICALUTAMIDE (50MG)ORALTABLETFalse2009-07-06BICALUTAMIDE
4ANDA078285_001discontinuedBICALUTAMIDE (50MG)ORALTABLETFalse2011-03-24BICALUTAMIDE
5ANDA078575_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
6ANDA078634_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-08-28BICALUTAMIDE
7ANDA078917_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
8ANDA079045_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2010-05-13BICALUTAMIDE
9ANDA079089_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
10ANDA079110_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
11ANDA079185_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2009-07-06BICALUTAMIDE
12ANDA091011_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2015-06-10BICALUTAMIDE
13ANDA200274_001RXBICALUTAMIDE (50MG)ORALTABLETFalseAB2015-05-21BICALUTAMIDE
14NDA020498_001RXBICALUTAMIDE (50MG)ORALTABLETTrueAB1995-10-04CASODEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1020d34eb-9560-4218-9d87-dfdeff705c3a (view SPL)These highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. Bicalutamide Tablets USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2009-07-061548686133
203607c0d-b772-435f-c985-ecce8ea8cafd (view SPL)These highlights do not include all the information needed to use CASODEX safely and effectively. See full prescribing information for CASODEX.CASODEX (bicalutamide) Tablet for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-02-2713003100705
30c3b8420-01ec-4a4a-97a2-222884522963 (view SPL)These highlights do not include all the information needed to use bicalutamide tablets safely and effectively. See full prescribing information for bicalutamide tablets. BICALUTAMIDE tablets, USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-04-275003787017
4175218a9-2795-4938-aeea-95750dc8b77c (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-151000636295321
5427a872b-1b0b-41cf-aca2-49ce0163c7e6 (view SPL)These highlights do not include all the information needed to use BICALUTAMIDE tablets safely and effectively. See full prescribing information for BICALUTAMIDE tablets. BICALUTAMIDE Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionSun Pharma Global Inc.ANALYSIS, MANUFACTURE2013-12-106416160485
6487ef40e-abb2-4107-b9e9-819e10c27321 (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-191521250709
74db9bad7-6256-4473-ac48-9e56c4a24d51 (view SPL)These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP.Bicalutamide Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.2010-11-161519910560
859df7b06-81d0-423c-9e80-9014d424b64c (view SPL)These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP.Bicalutamide Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionDava Pharmaceuticals, Inc.MANUFACTURE2009-07-171672530191
95bd7e54e-8497-4bc4-8964-151943db0626 (view SPL)These highlights do not include all the information needed to use CASODEX safely and effectively. See full prescribing information for CASODEX.CASODEX (bicalutamide) Tablet for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-01-272548684503
107bd07bdf-2742-c2f6-6314-bd175240b95f (view SPL)These highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. BICALUTAMIDE tablets USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionAvkare, Inc.2014-01-131422910168
117c295b64-ec39-42ec-9f02-da5b42e775e1 (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. BICALUTAMIDE Tablets USP for Oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2015-10-082167290023
127c9a8877-7364-4a3c-9345-78279fa282eb (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2014-05-081604290177
137cd5fd99-ea7f-432d-aa05-8c0ab4fffb75 (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral use Initial U.S. Approval : 1995prescriptionHuman PrescriptionApotex CorpMANUFACTURE2012-08-221605052642
1482d4877e-6ebf-4f75-a108-28dc840b07fc (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Bicalutamide Tablets USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionMajor2010-05-111009046019
1589c24844-4d2a-4ec6-bc28-adce7b82d0c0 (view SPL)These highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. BICALUTAMIDE tablets USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-075000930220
168b533fe4-287f-482c-b530-d9a5bf2ce40c (view SPL)These highlights do not include all the information needed to use BICALUTAMIDE tablets safely and effectively. See full prescribing information for BICALUTAMIDE tablets. BICALUTAMIDE tablets, USP for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-12-161473350485
178e26fbf0-511c-44d9-b484-372d7b50b55e (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Initial U.S. Approval: 1995prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-11-162658410613
18abaf380b-7434-426a-934b-73f6f094c82e (view SPL)These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP.Bicalutamide Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290226
19aeb2641f-4842-43ff-a4d8-d01b4ab3f47b (view SPL)These highlights do not include all the information needed to use bicalutamide tablets safely and effectively. See full prescribing information for bicalutamide tablets. Bicalutamide Tablets, USP for Oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionAmerican Health Packagingrepack2015-09-302680840612
20c267f783-1d39-4f27-83ed-8288577bf66d (view SPL)These highlights do not include all the information needed to use Bicalutamide Tablets, USP safely and effectively. See full prescribing information for Bicalutamide Tablets, USP.Bicalutamide Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionSynthon Pharmaceuticals, Inc.2010-10-141636720005
21c56d2445-ba72-4ce8-a4a4-1a9701f7d344 (view SPL)These highlights do not include all the information needed to use bicalutamide tablets USP safely and effectively. See full prescribing information for bicalutamide tablets USP. BICALUTAMIDE tablets USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-181691890298
22d0348cf0-f79a-4579-86c9-a5d25d688659 (view SPL)These highlights do not include all the information needed to use bicalutamide safely and effectively. See full prescribing information for bicalutamide. Initial U.S. Approval: 1995prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2014-04-285683820224
23f03d7e7a-cbe9-4788-894c-d30739f7e733 (view SPL)These highlights do not include all the information needed to use bicalutamide tabletssafely and effectively. See full prescribing information for bicalutamide tablets. BICALUTAMIDEtablets, USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionNorthstar Rx LlcMANUFACTURE2015-05-265167140571
24f32eadf6-d515-4307-a722-c49f0f1aef61 (view SPL)These highlights do not include all the information needed to use BICALUTAMIDE, USP safely and effectively. See full prescribing information for BICALUTAMIDE, USP.BICALUTAMIDE Tablets, USP for Oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionSandoz Inc2015-03-0316007815409

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