cabergoline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2011-08-23)
Oldest Current Product
2005-12-29
License(s)
NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\CABERGOLINE
FDAOB
ORAL\TABLET\CABERGOLINE
SPL Active
ORAL\TABLET\CABERGOLINE
SPL Moiety
ORAL\TABLET\CABERGOLINE

product(s) by strength(s)

cabergoline 0.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935420ANDATeva Pharmaceuticals Usa Inc2007-03-07CABERGOLINEORALTABLETANDA07775074b61e8a-7ae9-4996-85ec-df23c56de16f
2003782800ANDAMylan Pharmaceuticals Inc.2013-12-02CABERGOLINEORALTABLETANDA2029470e2a2cb6-e453-4060-95f4-a8ce4ccecc10
3162520536ANDAActavis Pharma, Inc.2008-04-21CABERGOLINEORALTABLETANDA078035ef345c23-20a8-40d4-bf3c-5650ed81e2f1
4498840673ANDAPar Pharmaceutical Companies, Inc.2005-12-29CABERGOLINEORALTABLETANDA076310ce51c53d-1cfa-4e5c-84d7-81024e10b4e8
5605052597ANDAApotex Corp2013-03-08CABERGOLINEORALTABLETANDA201503e563bf14-daca-9bfb-f324-1d243150528e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1597621005NDA AUTHORIZED GENERICGreenstone Llc2014-09-22CABERGOLINEORALTABLETNDA020664e497366b-a124-4d7f-bd45-a883c392d4bb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076310CABERGOLINEPAR PHARMACEUTICAL INC2005-12-29ANDA076310_001
2ANDA077750CABERGOLINEIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2007-03-07ANDA077750_001
3ANDA077843CABERGOLINEIMPAX LABORATORIES INC2007-07-03ANDA077843_001
4ANDA078035CABERGOLINEACTAVIS LABORATORIES FL INC2008-04-21ANDA078035_001
5ANDA201503CABERGOLINEAPOTEX CORP2013-03-08ANDA201503_001
6ANDA202947CABERGOLINEMYLAN PHARMACEUTICALS INC2013-12-02ANDA202947_001
7NDA020664DOSTINEXTruePHARMACIA AND UPJOHN CO1996-12-23NDA020664_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076310_001RXCABERGOLINE (0.5MG)ORALTABLETTrueAB2005-12-29CABERGOLINE
2ANDA077750_001RXCABERGOLINE (0.5MG)ORALTABLETFalseAB2007-03-07CABERGOLINE
3ANDA077843_001RXCABERGOLINE (0.5MG)ORALTABLETFalseAB2007-07-03CABERGOLINE
4ANDA078035_001RXCABERGOLINE (0.5MG)ORALTABLETFalseAB2008-04-21CABERGOLINE
5ANDA201503_001RXCABERGOLINE (0.5MG)ORALTABLETFalseAB2013-03-08CABERGOLINE
6ANDA202947_001RXCABERGOLINE (0.5MG)ORALTABLETFalseAB2013-12-02CABERGOLINE
7NDA020664_001discontinuedCABERGOLINE (0.5MG)ORALTABLETFalse1996-12-23DOSTINEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e2a2cb6-e453-4060-95f4-a8ce4ccecc10 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2011-10-013003782800
274b61e8a-7ae9-4996-85ec-df23c56de16f (view SPL)CABERGOLINE TABLETS USP 5420 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-1311000935420
3ce51c53d-1cfa-4e5c-84d7-81024e10b4e8 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.manufacture2011-08-233498840673
4e497366b-a124-4d7f-bd45-a883c392d4bb (view SPL)Cabergoline TabletsprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-09-113597621005
5e563bf14-daca-9bfb-f324-1d243150528e (view SPL)Cabergoline Tablets 0.5 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2011-11-071605052597
6ef345c23-20a8-40d4-bf3c-5650ed81e2f1 (view SPL)CABERGOLINE TABLETS, USPRx OnlyprescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, MANUFACTURE, PACK, RELABEL, REPACK2013-02-217162520536

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