FDA NDA · NDA022247

DUAVEE

conjugated estrogens/bazedoxifene

Sponsor: WYETH PHARMS

APPLICATION

NDA022247

TYPE

NDA

ORIGINAL APPROVAL

2013-10-03

LATEST ACTION

2024-03-04

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

DUAVEE · ReferencePrescription

BAZEDOXIFENE ACETATE EQ 20MG BASE, ESTROGENS, CONJUGATED 0.45MG · TABLET · ORAL

2024-03-04Labeling · Supplement 10 · standard — Letter ↗AP

2022-12-06Labeling · Supplement 7 · standard — Letter ↗AP

2019-12-18Labeling · Supplement 6 · standard — Label ↗AP

2017-11-01Labeling · Supplement 4 · standard — Label ↗AP

2015-09-25Labeling · Supplement 2 · standard — Label ↗AP

2015-07-23Labeling · Supplement 1 · standard — Letter ↗AP

2013-10-03Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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