FDA.reportPublic FDA data

Application 021367

Type
NDA
Sponsor
MILLICENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEMRINGESTRADIOL ACETATEINSERT, EXTENDED RELEASE;VAGINALEQ 0.05MG BASE/24HRYesNo
002FEMRINGESTRADIOL ACETATEINSERT, EXTENDED RELEASE;VAGINALEQ 0.1MG BASE/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5868Femringestradiol acetateAllergan, Inc.NDACurrent
0023-5869Femringestradiol acetateAllergan, Inc.NDACurrent
72495-201Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-201Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-201Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-201Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-202Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-202Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-202Femringestradiol acetateMillicent US, Inc.NDACurrent
72495-202Femringestradiol acetateMillicent US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77579SUPPL 2024-02-20
77553SUPPL 2024-02-16
75290SUPPL 2023-08-25
75273SUPPL 2023-08-23
75254SUPPL 2023-08-22
50321SUPPL2017-11-07
49366SUPPL2017-08-15
49365SUPPL2017-08-15
49292SUPPL2017-08-09
49291SUPPL2017-08-09
27617SUPPL2014-06-02
36784SUPPL2014-05-30
27616SUPPL2009-05-27
15320SUPPL2009-05-25
5199SUPPL2007-02-23
15319SUPPL2007-02-21
27615SUPPL2005-08-19
15318SUPPL2005-08-19
36783SUPPL2005-03-14
5198SUPPL2005-03-14
21623ORIG2003-07-16
5197ORIG2003-03-26
15317ORIG2003-03-21