Application 203505

Type: NDA
Sponsor: DUCHESNAY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OSPHENA	OSPEMIFENE	TABLET;ORAL	60MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N203505-001	OSPHENA	OSPEMIFENE	60MG	TABLET / ORAL		RLD, RS	2013-02-26

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203505-001	8236861	2026-08-11	U-1369		2013-03-25
N203505-001	8236861	2026-08-11	U-1370		2013-03-25
N203505-001	8236861	2026-08-11	U-905		2013-03-25
N203505-001	8642079	2028-07-09		Drug product	2014-02-20

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203505-001	OSPHENA	60MG	TABLET / ORAL	AB	RLD, RS	2013-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203505-001	OSPHENA	60MG	TABLET / ORAL		RLD, RS	2013-02-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203505-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203505-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203505-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203505-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203505-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203505-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203505-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203505-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203505-001	AB	1	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 683 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	6245819	2025-07-21	U-905		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	6245819	2025-07-21	U-1370		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-905		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-1369		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8236861	2026-08-11	U-1370		2013-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203505-001	8642079	2028-07-09		Drug product	2014-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-905			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-1370			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8470890	2024-02-13	U-1369			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-1370		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-905		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	8772353	2024-02-13	U-1369		2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	9241915	2024-02-13	U-1369		2016-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203505-001	9241915	2024-02-13	U-1370		2016-02-10	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203505-001	I-793	2022-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203505-001	I-793	2022-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203505-001	I-793	2022-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203505-001	I-793	2022-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203505-001	I-793	2022-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203505-001	I-793	2022-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203505-001	I-793	2022-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203505-001	I-793	2022-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203505-001	I-793	2022-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203505-001	I-793	2022-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203505-001	I-793	2022-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203505-001	I-793	2022-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203505-001	I-793	2022-01-25	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N203505-001	I-793	2022-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203505-001	I-793	2022-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203505-001	I-793	2022-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203505-001	I-793	2022-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203505-001	I-793	2022-01-25	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Osphena	OSPEMIFENE	Duchesnay USA, Inc.	9accbcc9-78ee-4f84-9b7e-704f2ab1c413	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 203505 application number: NDA203505

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59630-580	Osphena	Ospemifene	Shionogi Inc.	NDA	Current
59630-580	Osphena	Ospemifene	Shionogi Inc.	NDA	Current
59630-580	Osphena	Ospemifene	Shionogi Inc.	NDA	Current
59630-580	Osphena	Ospemifene	Shionogi Inc.	NDA	Current
59630-580	Osphena	Ospemifene	Shionogi Inc.	NDA	Current
75929-178	Osphena	Ospemifene	Pharma Packaging Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81213	SUPPL	2025-02-11
81178	SUPPL	2025-02-10
77572	SUPPL	2024-02-20
77550	SUPPL	2024-02-16
57536	SUPPL	2019-02-13
57354	SUPPL	2019-01-28
56190	SUPPL	2018-10-30
56149	SUPPL	2018-10-29
40308	SUPPL	2015-03-02
32434	SUPPL	2015-02-27
43438	ORIG	2013-03-28
40307	ORIG	2013-03-01
10228	ORIG	2013-02-28