Ergotamine Sublingual Tablet

Brand(s)
Ergomar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Rosedale Therapeutics, Llc (2012-09-08)
Oldest Current Product
2012-08-31
License(s)
ANDA
RxNORM
SUBLINGUAL TABLET\ERGOTAMINE
FDAOB
SUBLINGUAL\TABLET\ERGOTAMINE TARTRATE
SPL Active
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\ERGOTAMINE TARTRATE
SPL Moiety
SUBLINGUAL\TABLET, ORALLY DISINTEGRATING\ERGOTAMINE

product(s) by strength(s)

ergotamine tartrate 2 mg sublingual tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1108021202ErgomarANDARosedale Therapeutics, Llc2012-08-31ERGOTAMINE TARTRATESUBLINGUALTABLET, ORALLY DISINTEGRATINGANDA0876931bfd4827-5123-4dbb-8f94-7b097f5bfd5c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA086750WIGRETTESTrueORGANON USA INC1982-07-29ANDA086750_001
2ANDA087693ERGOMARROSEDALE THERAPEUTICS1983-02-24ANDA087693_001
3ANDA088337ERGOSTATTrueWATSON LABORATORIES INC1984-06-08ANDA088337_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA086750_001discontinuedERGOTAMINE TARTRATE (2MG)SUBLINGUALTABLETFalse1982-07-29WIGRETTES
2ANDA087693_001RXERGOTAMINE TARTRATE (2MG)SUBLINGUALTABLETTrue1983-02-24ERGOMAR
3ANDA088337_001discontinuedERGOTAMINE TARTRATE (2MG)SUBLINGUALTABLETFalse1984-06-08ERGOSTAT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11bfd4827-5123-4dbb-8f94-7b097f5bfd5c (view SPL)Ergomar Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)prescriptionHuman PrescriptionRosedale Therapeutics, LlcMANUFACTURE, PACK2012-09-081108021202

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