Bisoprolol Oral Tablet

Brand(s)
Zebeta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Women'S Health, Inc. (2010-11-16)
Oldest Current Product
1992-07-31
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BISOPROLOL
FDAOB
ORAL\TABLET\BISOPROLOL FUMARATE
SPL Active
ORAL\TABLET, COATED\BISOPROLOL FUMARATE
ORAL\TABLET, FILM COATED\BISOPROLOL FUMARATE
ORAL\TABLET\BISOPROLOL FUMARATE
SPL Moiety
ORAL\TABLET, COATED\BISOPROLOL
ORAL\TABLET, FILM COATED\BISOPROLOL
ORAL\TABLET\BISOPROLOL

product(s) by strength(s)

bisoprolol fumarate 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850061ZebetaNDATeva Women'S Health, Inc.1992-07-31BISOPROLOL FUMARATEORALTABLETNDA019982a11548a0-9c0f-4729-907c-75d8f99a6c85

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935271ANDATeva Pharmaceuticals Usa Inc2004-06-01BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA075644dba0b86a-5581-45a8-a956-716c2a718eb0
2001850774ANDAEon Labs, Inc.2000-11-16BISOPROLOL FUMARATEORALTABLET, COATEDANDA075643a1dc3675-ca21-4fdc-bc4d-e82381e31851
3003780524ANDAMylan Pharmaceuticals Inc.2012-09-24BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA075831621d9058-804a-4f46-a047-ea6e432eee49
4572370133ANDACitron Pharma Llc2006-12-27BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA077910c818c38d-ee37-4ceb-b078-611483b4f743
5658620087ANDAAurobindo Pharma Limited2006-12-27BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA0779102564646d-183c-4759-8726-155a4c22aa2b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950670ANDARebel Distributors Corp2009-09-21BISOPROLOL FUMARATEORALTABLET293000127ANDA078635d82243b9-3e56-4a2b-8750-cb95ec106885
2548685013ANDAPhysicians Total Care, Inc.2009-07-23BISOPROLOL FUMARATEORALTABLET, FILM COATED000935271ANDA075644b9bbf9ed-4781-42a9-bc3e-deda9f05e810

bisoprolol fumarate 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1512850060ZebetaNDATeva Women'S Health, Inc.1992-07-31BISOPROLOL FUMARATEORALTABLETNDA019982a11548a0-9c0f-4729-907c-75d8f99a6c85

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935270ANDATeva Pharmaceuticals Usa Inc2004-06-01BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA075644dba0b86a-5581-45a8-a956-716c2a718eb0
2001850771ANDAEon Labs, Inc.2000-11-16BISOPROLOL FUMARATEORALTABLET, COATEDANDA075643a1dc3675-ca21-4fdc-bc4d-e82381e31851
3003780523ANDAMylan Pharmaceuticals Inc.2012-09-24BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA075831621d9058-804a-4f46-a047-ea6e432eee49
4293000126ANDAUnichem Pharmaceuticals (Usa), Inc.2009-09-21BISOPROLOL FUMARATEORALTABLETANDA0786354f20df45-3f9c-4a91-b394-e93a08111ec3
5572370132ANDACitron Pharma Llc2006-12-27BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA077910c818c38d-ee37-4ceb-b078-611483b4f743
6658620086ANDAAurobindo Pharma Limited2006-12-27BISOPROLOL FUMARATEORALTABLET, FILM COATEDANDA0779102564646d-183c-4759-8726-155a4c22aa2b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950667ANDARebel Distributors Corp2009-09-21BISOPROLOL FUMARATEORALTABLET293000126ANDA078635d82243b9-3e56-4a2b-8750-cb95ec106885
2548685095ANDAPhysicians Total Care, Inc.2009-08-07BISOPROLOL FUMARATEORALTABLET, FILM COATED000935270ANDA075644b9bbf9ed-4781-42a9-bc3e-deda9f05e810
3636295173ANDABryant Ranch Prepack2009-09-21BISOPROLOL FUMARATEORALTABLET293000126ANDA078635428ef54d-8828-4756-a087-a1b7b2d6b8d6
4680840487ANDAAmerican Health Packaging2011-08-01BISOPROLOL FUMARATEORALTABLET, COATED001850771ANDA07564370f7b118-8a74-40d9-8a7c-c39744a6ebd7
5681514504ANDACarilion Materials Management2009-09-21BISOPROLOL FUMARATEORALTABLET293000126ANDA078635aca45d26-51c0-4257-9b5d-03e00e58196f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075474BISOPROLOL FUMARATETrueMUTUAL PHARMACEUTICAL CO INC2002-10-25ANDA075474_001, ANDA075474_002
2ANDA075643BISOPROLOL FUMARATESANDOZ INC2000-11-16ANDA075643_001, ANDA075643_002
3ANDA075644BISOPROLOL FUMARATETEVA PHARMACEUTICALS USA2001-06-26ANDA075644_001, ANDA075644_002
4ANDA075831BISOPROLOL FUMARATEMYLAN PHARMACEUTICALS INC2005-12-14ANDA075831_001, ANDA075831_002
5ANDA077910BISOPROLOL FUMARATEAUROBINDO PHARMA LTD2006-12-27ANDA077910_001, ANDA077910_002
6ANDA078635BISOPROLOL FUMARATEUNICHEM PHARMACEUTICALS (USA) INC2009-08-18ANDA078635_001, ANDA078635_002
7NDA019982ZEBETATEVA WOMENS HEALTH INC1992-07-31NDA019982_001, NDA019982_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075474_001discontinuedBISOPROLOL FUMARATE (5MG)ORALTABLETFalse2002-10-25BISOPROLOL FUMARATE
2ANDA075474_002discontinuedBISOPROLOL FUMARATE (10MG)ORALTABLETFalse2002-10-25BISOPROLOL FUMARATE
3ANDA075643_001RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2000-11-16BISOPROLOL FUMARATE
4ANDA075643_002RXBISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2000-11-16BISOPROLOL FUMARATE
5ANDA075644_001RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2001-06-26BISOPROLOL FUMARATE
6ANDA075644_002RXBISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2001-06-26BISOPROLOL FUMARATE
7ANDA075831_001RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2005-12-14BISOPROLOL FUMARATE
8ANDA075831_002RXBISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2005-12-14BISOPROLOL FUMARATE
9ANDA077910_001RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2006-12-27BISOPROLOL FUMARATE
10ANDA077910_002RXBISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2006-12-27BISOPROLOL FUMARATE
11ANDA078635_001RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB2009-08-18BISOPROLOL FUMARATE
12ANDA078635_002RXBISOPROLOL FUMARATE (10MG)ORALTABLETFalseAB2009-08-18BISOPROLOL FUMARATE
13NDA019982_001RXBISOPROLOL FUMARATE (10MG)ORALTABLETTrueAB1992-07-31ZEBETA
14NDA019982_002RXBISOPROLOL FUMARATE (5MG)ORALTABLETFalseAB1992-07-31ZEBETA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12564646d-183c-4759-8726-155a4c22aa2b (view SPL)Bisoprolol Fumarate Tablets, USPprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2012-01-115658620086, 658620087
2428ef54d-8828-4756-a087-a1b7b2d6b8d6 (view SPL)Bisoprolol Fumarate Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081000636295173
34f20df45-3f9c-4a91-b394-e93a08111ec3 (view SPL)Bisoprolol Fumarate Tablets USPprescriptionHuman PrescriptionUnichem Pharmaceuticals (Usa), Inc.2011-09-234293000126
4621d9058-804a-4f46-a047-ea6e432eee49 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-08-313003780523, 003780524
570f7b118-8a74-40d9-8a7c-c39744a6ebd7 (view SPL)BISOPROLOL FUMARATE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-104680840487
6a11548a0-9c0f-4729-907c-75d8f99a6c85 (view SPL)ZEBETA (Bisoprolol Fumarate) TabletsprescriptionHuman PrescriptionTeva Women'S Health, Inc.2010-11-164512850060, 512850061
7a1dc3675-ca21-4fdc-bc4d-e82381e31851 (view SPL)BISOPROLOL FUMARATE TABLETS USPprescriptionHuman PrescriptionEon Labs, Inc.2012-12-0617001850771, 001850774
8aca45d26-51c0-4257-9b5d-03e00e58196f (view SPL)Bisoprolol Fumarate Tablets USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-09-232681514504
9b9bbf9ed-4781-42a9-bc3e-deda9f05e810 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-09-252548685013, 548685095
10c818c38d-ee37-4ceb-b078-611483b4f743 (view SPL)Bisoprolol Fumarate Tablets, USPprescriptionHuman PrescriptionCitron Pharma Llc2015-06-271572370132, 572370133
11d82243b9-3e56-4a2b-8750-cb95ec106885 (view SPL)Bisoprolol Fumarate Tablets USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-101216950667, 216950670
12dba0b86a-5581-45a8-a956-716c2a718eb0 (view SPL)BISOPROLOL FUMARATE TABLETS USP52705271Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-07-146000935270, 000935271

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