FDA.reportPublic FDA data

Application 208470

Type
NDA
Sponsor
AMAG PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INTRAROSAPRASTERONEINSERT;VAGINAL6.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64011-601IntrarosaPrasteroneAMAG Pharmaceuticals, Inc.NDACurrent
64011-601IntrarosaPrasteroneAMAG Pharmaceuticals, Inc.NDACurrent
64011-601IntrarosaPrasteroneAMAG Pharmaceuticals, Inc.NDACurrent
64011-601IntrarosaPrasteroneAMAG Pharmaceuticals, Inc.NDACurrent
64011-601IntrarosaPrasteroneAMAG Pharmaceuticals, Inc.NDACurrent
72495-401IntrarosaPrasteroneMillicent US, Inc.NDACurrent
72495-401IntrarosaPrasteroneMillicent US, Inc.NDACurrent
72495-401IntrarosaPrasteroneMillicent US, Inc.NDACurrent
72495-501IntrarosaPrasteroneMillicent US, Inc.NDACurrent
72495-501IntrarosaPrasteroneMillicent US, Inc.NDACurrent
72495-501IntrarosaPrasteroneMillicent US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52624SUPPL2018-02-14
51046ORIG2018-01-12
45905ORIG2016-11-17
45902ORIG2016-11-16