Bromocriptine Oral Capsule

Brand(s)
Parlodel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Validus Pharmaceuticals Llc (2014-05-07)
Oldest Current Product
2009-01-23
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\BROMOCRIPTINE
FDAOB
ORAL\CAPSULE\BROMOCRIPTINE MESYLATE
ORAL\TABLET\BROMOCRIPTINE MESYLATE
SPL Active
ORAL\CAPSULE, GELATIN COATED\BROMOCRIPTINE MESYLATE
ORAL\CAPSULE\BROMOCRIPTINE MESYLATE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\BROMOCRIPTINE
ORAL\CAPSULE\BROMOCRIPTINE

product(s) by strength(s)

bromocriptine 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1306980201ParlodelNDAValidus Pharmaceuticals Llc2014-04-28BROMOCRIPTINE MESYLATEORALCAPSULE, GELATIN COATEDNDA017962fc2a08dd-4fb6-4ac4-9082-f99552fae25c

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003787096ANDAMylan Pharmaceuticals Inc.2013-06-17BROMOCRIPTINE MESYLATEORALCAPSULEANDA07722672d8eefe-c066-41b6-8922-9586f1cf47a1
2658410654ANDACadila Healthcare Limited2009-01-23BROMOCRIPTINE MESYLATEORALCAPSULEANDA07889997e7e051-ff64-4381-a869-6c1c364ad822
3683820110ANDAZydus Pharmaceuticals (Usa) Inc.2009-01-23BROMOCRIPTINE MESYLATEORALCAPSULEANDA078899d69003ee-0b6f-47a9-834e-ba59c02f566c

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA074631BROMOCRIPTINE MESYLATELEK PHARMACEUTICALS D D1998-01-13ANDA074631_001Bromocriptine Oral Tablet
2ANDA075100BROMOCRIPTINE MESYLATETrueLEK PHARMACEUTICAL AND CHEMICAL CO DD1998-12-10ANDA075100_001Bromocriptine Oral Tablet
3ANDA076962BROMOCRIPTINE MESYLATEMYLAN PHARMACEUTICALS INC2004-09-24ANDA076962_001Bromocriptine Oral Tablet
4ANDA077226BROMOCRIPTINE MESYLATEMYLAN PHARMACEUTICALS INC2005-04-04ANDA077226_001Bromocriptine Oral Tablet
5ANDA077646BROMOCRIPTINE MESYLATEPADDOCK LABORATORIES LLC2008-10-01ANDA077646_001Bromocriptine Oral Tablet
6ANDA078899BROMOCRIPTINE MESYLATEZYDUS PHARMACEUTICALS USA INC2008-07-30ANDA078899_001Bromocriptine Oral Tablet
7NDA017962PARLODELUS PHARMACEUTICALS HOLDINGS I LLCNDA017962_001, NDA017962_002Bromocriptine Oral Tablet
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 Tablet

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 Tablet
2p5716957 (view patent)2015-02-10NDA020866Bromocriptine Oral Tablet
3p7888310 (view patent)2023-07-25NDA020866Bromocriptine Oral Tablet
4p8137992 (view patent)2023-07-25NDA020866Bromocriptine Oral Tablet
5p8137993 (view patent)2023-07-25NDA020866Bromocriptine Oral Tablet
6p8137994 (view patent)2023-07-25NDA020866Bromocriptine Oral Tablet
7p8431155 (view patent)2032-04-30NDA020866Bromocriptine Oral Tablet
8p8613947 (view patent)2032-04-30NDA020866Bromocriptine Oral Tablet
9p8877708 (view patent)2030-06-07NDA020866Bromocriptine Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
172d8eefe-c066-41b6-8922-9586f1cf47a1 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-02-284003787096, 003782042Bromocriptine Oral Tablet
297e7e051-ff64-4381-a869-6c1c364ad822 (view SPL)Bromocriptine Mesylate Capsules, USPprescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2012-12-044658410654
3d69003ee-0b6f-47a9-834e-ba59c02f566c (view SPL)Bromocriptine Mesylate Capsules, USPprescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.Analysis, Manufacture2013-05-285683820110
4fc2a08dd-4fb6-4ac4-9082-f99552fae25c (view SPL)Parlodel SnapTabs (bromocriptine mesylate) tablets, USP (bromocriptine mesylate) capsules, USP Rx only Prescribing InformationprescriptionHuman PrescriptionValidus Pharmaceuticals LlcMANUFACTURE2014-05-074306980201, 306980202Bromocriptine Oral Tablet

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