Methylergonovine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2015-08-28)
Oldest Current Product
2010-06-21
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\METHYLERGONOVINE
FDAOB
INJECTION\INJECTION\METHYLERGONOVINE MALEATE\rdfq
ORAL\TABLET\METHYLERGONOVINE MALEATE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\METHYLERGONOVINE MALEATE
INTRAMUSCULAR\INJECTION\METHYLERGONOVINE MALEATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\METHYLERGONOVINE
INTRAMUSCULAR\INJECTION\METHYLERGONOVINE

product(s) by strength(s)

methylergonovine maleate 0.2 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170740ANDAAmerican Regent, Inc.2010-06-21METHYLERGONOVINE MALEATEINTRAMUSCULARINJECTION, SOLUTIONANDA090193a9a3079e-b62b-4858-920e-d8f5cb38481e
2174780501ANDAAkorn2011-03-02METHYLERGONOVINE MALEATEINTRAMUSCULARINJECTIONANDA040889b4c5f70e-da62-4d1d-a3e0-6fe5e45bb65b
3637040004ANDAPharmacist Pharmaceutical, Llc2010-11-01METHYLERGONOVINE MALEATEINTRAMUSCULARINJECTION, SOLUTIONANDA04088917ee0c79-ac98-4400-ae77-985978fca07e

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA040889METHYLERGONOVINE MALEATEERGOJECT LLC2010-09-13ANDA040889_001Methylergonovine Oral Tablet
2ANDA090193METHYLERGONOVINE MALEATELUITPOLD PHARMACEUTICALS INC2008-11-24ANDA090193_001Methylergonovine Oral Tablet
3NDA006035METHERGINEEDISON THERAPEUTICS LLCNDA006035_003, NDA006035_004Methylergonovine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040889_001RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONFalseAP2010-09-13METHYLERGONOVINE MALEATE
2ANDA090193_001RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONFalseAP2008-11-24METHYLERGONOVINE MALEATE
3NDA006035_003RXMETHYLERGONOVINE MALEATE (0.2MG)ORALTABLETTrueABMETHERGINE
4NDA006035_004RXMETHYLERGONOVINE MALEATE (0.2MG/ML)INJECTIONTrueAPMETHERGINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
117ee0c79-ac98-4400-ae77-985978fca07e (view SPL)Methylergonovine Maleate Injection, USPprescriptionHuman PrescriptionPharmacist Pharmaceutical, LlcANALYSIS, MANUFACTURE2013-02-133637040004
2a9a3079e-b62b-4858-920e-d8f5cb38481e (view SPL)Methylergonovine Maleate Injection, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE2013-02-062005170740
3b4c5f70e-da62-4d1d-a3e0-6fe5e45bb65b (view SPL)Methylergonovine MaleateInjection, USPprescriptionHuman PrescriptionAkornANALYSIS, MANUFACTURE2015-08-284174780501

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