Dihydroergotamine Injectable Solution

Brand(s)
DHE-45
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America (2014-12-30)
Oldest Current Product
2001-10-03
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DIHYDROERGOTAMINE
FDAOB
INJECTION\INJECTION\DIHYDROERGOTAMINE MESYLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\DIHYDROERGOTAMINE MESYLATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\DIHYDROERGOTAMINE

product(s) by strength(s)

dihydroergotamine mesylate 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1664900041DHE-45NDAValeant Pharmaceuticals North America2001-10-03DIHYDROERGOTAMINE MESYLATEINTRAMUSCULARINJECTION, SOLUTIONNDA005929fe826e6a-75c8-43ed-9c36-f8263ec35aff

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005740850ANDAPaddock Laboratories, Llc2003-04-29DIHYDROERGOTAMINE MESYLATEINTRAMUSCULARINJECTION, SOLUTIONANDA040475111f628a-7e1e-4d47-8ac1-f898cbfc9b74

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA040453DIHYDROERGOTAMINE MESYLATEBEDFORD LABORATORIES2003-06-09ANDA040453_001
2ANDA040475DIHYDROERGOTAMINE MESYLATEPADDOCK LABORATORIES LLC2003-04-28ANDA040475_001
3NDA005929D.H.E. 45VALEANT PHARMACEUTICALS INTERNATIONALNDA005929_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040453_001RXDIHYDROERGOTAMINE MESYLATE (1MG/ML)INJECTIONFalseAP2003-06-09DIHYDROERGOTAMINE MESYLATE
2ANDA040475_001RXDIHYDROERGOTAMINE MESYLATE (1MG/ML)INJECTIONFalseAP2003-04-28DIHYDROERGOTAMINE MESYLATE
3NDA005929_001RXDIHYDROERGOTAMINE MESYLATE (1MG/ML)INJECTIONTrueAPD.H.E. 45

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1111f628a-7e1e-4d47-8ac1-f898cbfc9b74 (view SPL)Dihydroergotamine Mesylate Injection, USP Rx OnlyprescriptionHuman PrescriptionPaddock Laboratories, LlcANALYSIS2014-06-244005740850
2fe826e6a-75c8-43ed-9c36-f8263ec35aff (view SPL)D.H.E. 45 (dihydroergotamine mesylate) Injection, USPprescriptionHuman PrescriptionValeant Pharmaceuticals North AmericaMANUFACTURE2014-12-305664900041

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