FDA.reportPublic FDA data

Application 022247

Type
NDA
Sponsor
WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUAVEEBAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATEDTABLET;ORALEQ 20MG BASE;0.45MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1123Duaveeconjugated estrogens/bazedoxifeneWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
63539-112Duaveeconjugated estrogens/bazedoxifeneU.S. PharmaceuticalsNDACurrent
63539-122Duaveeconjugated estrogens/bazedoxifeneU.S. PharmaceuticalsNDACurrent
63539-122Duaveeconjugated estrogens/bazedoxifeneU.S. PharmaceuticalsNDACurrent
63539-122Duaveeconjugated estrogens/bazedoxifeneU.S. PharmaceuticalsNDACurrent
63539-122Duaveeconjugated estrogens/bazedoxifeneU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77725SUPPL 2024-03-06
77712SUPPL 2024-03-05
72820SUPPL2022-12-07
72815SUPPL2022-12-07
61386SUPPL2019-12-23
61352SUPPL2019-12-19
50269SUPPL2017-11-02
17116SUPPL2015-10-07
29437SUPPL2015-09-28
17115SUPPL2013-11-21
17113ORIG2013-11-21
42461ORIG2013-11-15
17114ORIG2013-10-25
7083SUPPL2013-10-24
7082ORIG2013-10-24