Application 208564

Type
NDA
Sponsor
THERAPEUTICSMD INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMVEXXYESTRADIOLINSERT;VAGINAL0.004MGYesNo
002IMVEXXYESTRADIOLINSERT;VAGINAL0.01MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-104IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent
50261-110IMVEXXYestradiolTherapeuticsMD, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77575SUPPL 2024-02-20
77554SUPPL 2024-02-16
69340SUPPL2021-11-17
69335SUPPL2021-11-17
61033SUPPL2019-11-22
61021SUPPL2019-11-22
57394ORIG2019-02-01
54411ORIG2018-06-01
54392ORIG2018-05-31