Caffeine / Ergotamine Oral Tablet

Brand(s)
Cafergot
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2012-05-14)
Oldest Current Product
1982-01-01
License(s)
ANDA
RxNORM
ORAL TABLET\CAFFEINE:ERGOTAMINE
FDAOB
ORAL\TABLET\CAFFEINE: ERGOTAMINE TARTRATE
SPL Active
ORAL\TABLET, FILM COATED\CAFFEINE: ERGOTAMINE TARTRATE
ORAL\TABLET\CAFFEINE: ERGOTAMINE TARTRATE
SPL Moiety
ORAL\TABLET, FILM COATED\CAFFEINE: ERGOTAMINE
ORAL\TABLET\CAFFEINE: ERGOTAMINE

product(s) by strength(s)

caffeine 100 mg / ergotamine tartrate 1 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001432120ANDAWest-Ward Pharmaceutical Corp2004-09-17CAFFEINE, ERGOTAMINE TARTRATEORALTABLET, FILM COATEDANDA04051019479eeb-f507-48a8-bca3-c9cc0a0f6021
2007815405CafergotANDASandoz Inc1982-01-01CAFFEINE, ERGOTAMINE TARTRATEORALTABLET, FILM COATEDANDA084294b4a06de6-f837-43a8-ae7a-aadb38dd2a7d
3466720198ANDAMikart, Inc.2005-09-16CAFFEINE, ERGOTAMINE TARTRATEORALTABLET, FILM COATEDANDA0405906a105e44-b558-45c1-9c91-fe1f3dfc5bd5

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790067ANDAKaiser Foundations Hospitals2010-06-25CAFFEINE, ERGOTAMINE TARTRATEORALTABLET602580070ANDA040590ed1ede57-1317-491a-9ebb-edee9aef5b3b
2001790089CafergotANDAKaiser Foundations Hospitals2011-04-21CAFFEINE, ERGOTAMINE TARTRATEORALTABLET007815405ANDA0842941c066197-dea6-4705-9b4a-8703dd564a2a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040510ERGOTAMINE TARTRATE AND CAFFEINEHIKMA INTERNATIONAL PHARMACEUTICALS LLC2004-09-17ANDA040510_001
2ANDA040590ERGOTAMINE TARTRATE AND CAFFEINEMIKART INC2005-09-16ANDA040590_001
3ANDA084294CAFERGOTSANDOZ INCANDA084294_001
4ANDA086562WIGRAINETrueORGANON USA INCANDA086562_001
5NDA006620CAFERGOTTrueNOVARTIS PHARMACEUTICALS CORPNDA006620_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040510_001RXCAFFEINE (100MG), ERGOTAMINE TARTRATE (1MG)ORALTABLETFalseAA2004-09-17ERGOTAMINE TARTRATE AND CAFFEINE
2ANDA040590_001RXCAFFEINE (100MG), ERGOTAMINE TARTRATE (1MG)ORALTABLETFalseAA2005-09-16ERGOTAMINE TARTRATE AND CAFFEINE
3ANDA084294_001RXERGOTAMINE TARTRATE (1MG), CAFFEINE (100MG)ORALTABLETTrueAACAFERGOT
4ANDA086562_001discontinuedERGOTAMINE TARTRATE (1MG), CAFFEINE (100MG)ORALTABLETFalseWIGRAINE
5NDA006620_001discontinuedCAFFEINE (100MG), ERGOTAMINE TARTRATE (1MG)ORALTABLETFalseCAFERGOT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
119479eeb-f507-48a8-bca3-c9cc0a0f6021 (view SPL)Ergotamine Tartrate and CaffeineprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2013-04-102001432120
21c066197-dea6-4705-9b4a-8703dd564a2a (view SPL)CAFERGOT (Ergotamine Tartrate and Caffeine) Tablets, USP1 mg/ 100 mgprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2011-04-251001790089
36a105e44-b558-45c1-9c91-fe1f3dfc5bd5 (view SPL)prescriptionHuman PrescriptionMikart, Inc.2015-08-312466720198
4b4a06de6-f837-43a8-ae7a-aadb38dd2a7d (view SPL)Cafergot (ergotamine tartrate and caffeine tablets, USP)prescriptionHuman PrescriptionSandoz Inc2012-05-1410007815405
5ed1ede57-1317-491a-9ebb-edee9aef5b3b (view SPL)Ergotamine Tartrate and Caffeine Tablets, USP1 mg/ 100 mgprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-06-281001790067

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