Bromocriptine Oral Tablet

Brand(s)
Cycloset, Parlodel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Santarus, Inc. (2015-10-28)
Oldest Current Product
1998-01-13
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\BROMOCRIPTINE
FDAOB
ORAL\CAPSULE\BROMOCRIPTINE MESYLATE
ORAL\TABLET\BROMOCRIPTINE MESYLATE
SPL Active
ORAL\TABLET\BROMOCRIPTINE MESYLATE
SPL Moiety
ORAL\TABLET\BROMOCRIPTINE

product(s) by strength(s)

bromocriptine 0.8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1680120258CyclosetNDASantarus, Inc.2010-11-15BROMOCRIPTINE MESYLATEORALTABLETNDA0208663e719d6a-342e-428b-93d3-377d31cb15c7

bromocriptine 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1306980202ParlodelNDAValidus Pharmaceuticals Llc2014-06-20BROMOCRIPTINE MESYLATEORALTABLETNDA017962fc2a08dd-4fb6-4ac4-9082-f99552fae25c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003782042ANDAMylan Pharmaceuticals Inc.2013-06-06BROMOCRIPTINE MESYLATEORALTABLETANDA07696272d8eefe-c066-41b6-8922-9586f1cf47a1
2005740106ANDAPaddock Laboratories, Llc2008-10-01BROMOCRIPTINE MESYLATEORALTABLETANDA0776460ee2da00-faf8-4c51-a696-9462fa4f6050
3007815325ANDASandoz Inc1998-01-13BROMOCRIPTINE MESYLATEORALTABLETANDA074631c43c300d-8aec-4020-984a-42c1a917c08f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790165ANDAKaiser Foundations Hospitals2014-10-10BROMOCRIPTINE MESYLATEORALTABLET003782042ANDA0769628761f36b-2056-4a0e-a5e4-027ba4aa8d02
2548685667ANDAPhysicians Total Care, Inc.2006-09-08BROMOCRIPTINE MESYLATEORALTABLET003782042ANDA076962b1486ede-e493-4dfe-8cd8-67a5a94cc0cc
3681511305ANDACarilion Materials Management2008-10-01BROMOCRIPTINE MESYLATEORALTABLET005740106ANDA077646b89ff149-e33a-46cb-9649-64583e78a7ee

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA074631BROMOCRIPTINE MESYLATELEK PHARMACEUTICALS D D1998-01-13ANDA074631_001Bromocriptine Oral Capsule
2ANDA075100BROMOCRIPTINE MESYLATETrueLEK PHARMACEUTICAL AND CHEMICAL CO DD1998-12-10ANDA075100_001Bromocriptine Oral Capsule
3ANDA076962BROMOCRIPTINE MESYLATEMYLAN PHARMACEUTICALS INC2004-09-24ANDA076962_001Bromocriptine Oral Capsule
4ANDA077226BROMOCRIPTINE MESYLATEMYLAN PHARMACEUTICALS INC2005-04-04ANDA077226_001Bromocriptine Oral Capsule
5ANDA077646BROMOCRIPTINE MESYLATEPADDOCK LABORATORIES LLC2008-10-01ANDA077646_001Bromocriptine Oral Capsule
6ANDA078899BROMOCRIPTINE MESYLATEZYDUS PHARMACEUTICALS USA INC2008-07-30ANDA078899_001Bromocriptine Oral Capsule
7NDA017962PARLODELUS PHARMACEUTICALS HOLDINGS I LLCNDA017962_001, NDA017962_002Bromocriptine Oral Capsule
8NDA020866CYCLOSETVEROSCIENCE LLC2009-05-05p8613947, IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES, SUBSTANCE
p8877708, TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING BROMOCRIPTINE MESYLATE AND A FIRST-PHASE INSULIN SECRETAGOGUE WHEREIN THE COMBINED THERAPEUTIC EFFECT IS GREATER THAN THE ADDITIVE EFFECT OF ADMINISTERING EACH AGENT ALONE, SUBSTANCE
p8137994, IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
p8137993, IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
p8137992, IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
p8431155, IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES, SUBSTANCE
p7888310, IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
p5679685, SUBSTANCE
p5716957, IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
NDA020866_001Bromocriptine Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074631_001RXBROMOCRIPTINE MESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB1998-01-13BROMOCRIPTINE MESYLATE
2ANDA075100_001discontinuedBROMOCRIPTINE MESYLATE (EQ 5MG BASE)ORALCAPSULEFalse1998-12-10BROMOCRIPTINE MESYLATE
3ANDA076962_001RXBROMOCRIPTINE MESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2004-09-24BROMOCRIPTINE MESYLATE
4ANDA077226_001RXBROMOCRIPTINE MESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2005-04-04BROMOCRIPTINE MESYLATE
5ANDA077646_001RXBROMOCRIPTINE MESYLATE (EQ 2.5MG BASE)ORALTABLETFalseAB2008-10-01BROMOCRIPTINE MESYLATE
6ANDA078899_001RXBROMOCRIPTINE MESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2008-07-30BROMOCRIPTINE MESYLATE
7NDA017962_001RXBROMOCRIPTINE MESYLATE (EQ 2.5MG BASE)ORALTABLETTrueABPARLODEL
8NDA017962_002RXBROMOCRIPTINE MESYLATE (EQ 5MG BASE)ORALCAPSULETrueAB1982-03-01PARLODEL
9NDA020866_001RXBROMOCRIPTINE MESYLATE (EQ 0.8MG BASE)ORALTABLETTrue2009-05-05CYCLOSET

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5679685 (view patent)2014-10-21NDA020866Bromocriptine Oral Capsule
2p5716957 (view patent)2015-02-10NDA020866Bromocriptine Oral Capsule
3p7888310 (view patent)2023-07-25NDA020866Bromocriptine Oral Capsule
4p8137992 (view patent)2023-07-25NDA020866Bromocriptine Oral Capsule
5p8137993 (view patent)2023-07-25NDA020866Bromocriptine Oral Capsule
6p8137994 (view patent)2023-07-25NDA020866Bromocriptine Oral Capsule
7p8431155 (view patent)2032-04-30NDA020866Bromocriptine Oral Capsule
8p8613947 (view patent)2032-04-30NDA020866Bromocriptine Oral Capsule
9p8877708 (view patent)2030-06-07NDA020866Bromocriptine Oral Capsule

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10ee2da00-faf8-4c51-a696-9462fa4f6050 (view SPL)Bromocriptine Mesylate Tablets, USPprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-06-243005740106
23e719d6a-342e-428b-93d3-377d31cb15c7 (view SPL)These highlights do not include all the information needed to use CYCLOSET safely and effectively. See full prescribing information for CYCLOSET. CYCLOSET (bromocriptine mesylate) Tablets, for oral useInitial U.S. Approval: 1978prescriptionHuman PrescriptionSantarus, Inc.API MANUFACTURE, MANUFACTURE2015-10-283680120258
372d8eefe-c066-41b6-8922-9586f1cf47a1 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-02-284003782042, 003787096Bromocriptine Oral Capsule
48761f36b-2056-4a0e-a5e4-027ba4aa8d02 (view SPL)prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-10-241001790165
5b1486ede-e493-4dfe-8cd8-67a5a94cc0cc (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-011548685667
6b89ff149-e33a-46cb-9649-64583e78a7ee (view SPL)Bromocriptine Mesylate Tablets, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-12-182681511305
7c43c300d-8aec-4020-984a-42c1a917c08f (view SPL)Bromocriptine Mesylate Tablets, USP 2.5 mgprescriptionHuman PrescriptionSandoz Inc2015-03-125007815325
8fc2a08dd-4fb6-4ac4-9082-f99552fae25c (view SPL)Parlodel SnapTabs (bromocriptine mesylate) tablets, USP (bromocriptine mesylate) capsules, USP Rx only Prescribing InformationprescriptionHuman PrescriptionValidus Pharmaceuticals LlcMANUFACTURE2014-05-074306980202, 306980201Bromocriptine Oral Capsule

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