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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022247
Company: WYETH PHARMS

Products on NDA 022247

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUAVEE	BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED	EQ 20MG BASE;0.45MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022247

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/2013	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022247_duavee_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022247s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022247Orig1s010ltr.pdf
12/06/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022247s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022247Orig1s007ltr.pdf
12/18/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022247s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022247Orig1s006ltr.pdf
11/01/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022247s004lbl.pdf
09/25/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022247s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022247Orig1s002ltr.pdf
07/23/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022247Orig1s001ltr.pdf

Labels for NDA 022247

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022247s010lbl.pdf
12/06/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022247s007lbl.pdf
12/18/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022247s006lbl.pdf
11/01/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022247s004lbl.pdf
09/25/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022247s002lbl.pdf
07/23/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf
10/03/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247Orig1s001lbl.pdf
10/03/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022247s000lbl.pdf

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