Application 022247

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUAVEE	BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED	TABLET;ORAL	EQ 20MG BASE;0.45MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022247-001	DUAVEE	BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED	EQ 20MG BASE;0.45MG	TABLET / ORAL		RLD, RS	2013-10-03

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31
N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022247-001	DUAVEE	EQ 20MG BASE;0.45MG	TABLET / ORAL	RLD, RS	2013-10-03	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	7683051	2027-03-10	U-594	Drug substance, Drug product	2013-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022247-001	7683051	2027-03-10	U-904	Drug substance, Drug product	2013-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	6479535	2024-05-06	U-594	Drug product	2013-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022247-001	6479535	2024-05-06	U-904	Drug product	2013-10-31	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Duavee	CONJUGATED ESTROGENS/BAZEDOXIFENE	U.S. Pharmaceuticals	e16705d8-4472-4f83-96ac-69fa2be066cb	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022247 application number: NDA022247 ndc (product): 63539-122
Duavee	CONJUGATED ESTROGENS/BAZEDOXIFENE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	e1b75458-2e5b-46b9-92c6-fa6daba3770f	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022247 application number: NDA022247 ndc (product): 0008-1123

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0008-1123	Duavee	conjugated estrogens/bazedoxifene	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
63539-112	Duavee	conjugated estrogens/bazedoxifene	U.S. Pharmaceuticals	NDA	Current
63539-122	Duavee	conjugated estrogens/bazedoxifene	U.S. Pharmaceuticals	NDA	Current
63539-122	Duavee	conjugated estrogens/bazedoxifene	U.S. Pharmaceuticals	NDA	Current
63539-122	Duavee	conjugated estrogens/bazedoxifene	U.S. Pharmaceuticals	NDA	Current
63539-122	Duavee	conjugated estrogens/bazedoxifene	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77725	SUPPL	2024-03-06
77712	SUPPL	2024-03-05
72820	SUPPL	2022-12-07
72815	SUPPL	2022-12-07
61386	SUPPL	2019-12-23
61352	SUPPL	2019-12-19
50269	SUPPL	2017-11-02
17116	SUPPL	2015-10-07
29437	SUPPL	2015-09-28
17115	SUPPL	2013-11-21
17113	ORIG	2013-11-21
42461	ORIG	2013-11-15
17114	ORIG	2013-10-25
7083	SUPPL	2013-10-24
7082	ORIG	2013-10-24