FDA.reportPublic FDA data

Application 091577

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLERGONOVINE MALEATEMETHYLERGONOVINE MALEATETABLET;ORAL0.2MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27437-050MethergineMethylergonovine maleateLupin Pharmaceuticals, Inc.ANDACurrent
27437-050MethergineMethylergonovine maleateLupin PharmaANDACurrent
40032-140Methylergonovine MaleateMethylergonovine MaleateNovel Laboratories, Inc.ANDACurrent
43386-140Methylergonovine MaleateMethylergonovine MaleateLupin Pharmaceuticals,Inc.ANDACurrent
50268-544Methylergonovine MaleateMethylergonovine MaleateAvPAKANDACurrent
63704-006methylergonovine maleatemethylergonovine maleatePharmacist Pharmaceutical, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31539ORIG2011-05-05