Caffeine / Ergotamine Rectal Suppository

Brand(s)
Migergot
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Crealta Pharmaceuticals Llc (2014-04-21)
Oldest Current Product
1983-10-30
License(s)
ANDA
RxNORM
RECTAL SUPPOSITORY\CAFFEINE:ERGOTAMINE
FDAOB
RECTAL\SUPPOSITORY\CAFFEINE: ERGOTAMINE TARTRATE
SPL Active
RECTAL\SUPPOSITORY\CAFFEINE: ERGOTAMINE TARTRATE
SPL Moiety
RECTAL\SUPPOSITORY\CAFFEINE: ERGOTAMINE

product(s) by strength(s)

caffeine 100 mg / ergotamine tartrate 2 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130166MigergotANDAG&W Laboratories, Inc.1983-10-30CAFFEINE, ERGOTAMINE TARTRATERECTALSUPPOSITORYANDA0865573a31ad0c-7bdd-544b-f5df-a99d04cf541c
2608090166MigergotANDACrealta Pharmaceuticals Llc2014-10-01CAFFEINE, ERGOTAMINE TARTRATERECTALSUPPOSITORYANDA086557990f47f3-a08a-496a-b0c0-ae7193a11b01

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086557MIGERGOTCREALTA PHARMACEUTICALS LLC1983-10-04ANDA086557_001
2NDA009000CAFERGOTTrueNOVARTIS PHARMACEUTICALS CORPNDA009000_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA086557_001RXERGOTAMINE TARTRATE (2MG), CAFFEINE (100MG)RECTALSUPPOSITORYTrue1983-10-04MIGERGOT
2NDA009000_002discontinuedERGOTAMINE TARTRATE (2MG), CAFFEINE (100MG)RECTALSUPPOSITORYFalseCAFERGOT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13a31ad0c-7bdd-544b-f5df-a99d04cf541c (view SPL)prescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2011-09-074007130166
2990f47f3-a08a-496a-b0c0-ae7193a11b01 (view SPL)ERGOTAMINE TARTRATE and CAFFEINE SUPPOSITORIES USP (For Rectal Administration)prescriptionHuman PrescriptionCrealta Pharmaceuticals Llc2014-04-211608090166

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