Application 090193

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATEINJECTABLE;INJECTION0.2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-0740Methylergonovine MaleateMethylergonovine MaleateAmerican Regent, Inc.ANDACurrent
0517-0740Methylergonovine MaleateMethylergonovine MaleateAmerican Regent, Inc.ANDACurrent
0517-0740Methylergonovine MaleateMethylergonovine MaleateAmerican Regent, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39608ORIG2009-01-16
9262ORIG2008-11-28