Application 203415

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XTANDI	ENZALUTAMIDE	CAPSULE;ORAL	40MG	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
N203415-001	XTANDI	ENZALUTAMIDE	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203415-001	9126941	2026-05-15	U-1588		2015-10-07
N203415-001	9126941	2026-05-15	U-2345		2015-10-07
N203415-001	9126941	2026-05-15	U-2708		2015-10-07
N203415-001	9126941	2026-05-15	U-3763		2015-10-07
N203415-001	8183274	2026-08-24	U-1281		2012-09-27
N203415-001	8183274	2026-08-24	U-1588		2012-09-27
N203415-001	8183274	2026-08-24	U-2345		2012-09-27
N203415-001	8183274	2026-08-24	U-2708		2012-09-27
N203415-001	8183274	2026-08-24	U-3763		2012-09-27
N203415-001	7709517	2027-08-13		Drug substance, Drug product	2012-09-27
N203415-001	12161628	2037-02-23	U-4101		2025-01-08
N203415-001	12161628	2037-02-23	U-4102		2025-01-08
N203415-001	12161628	2037-02-23	U-4103		2025-01-08
N203415-001	12161628	2037-02-23	U-4104		2025-01-08

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N203415-001	I-926	2026-11-17

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203415-001	XTANDI	40MG	CAPSULE / ORAL		RLD, RS	2012-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203415-001	XTANDI	40MG	CAPSULE / ORAL	AB	RLD, RS	2012-08-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203415-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203415-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203415-001	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203415-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203415-001	AB	1	`d06236e962d9…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203415-001	AB	1	`5c6f7cd8ea54…`
2022-03-09 01:35 UTC	2022-03	N203415-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203415-001	AB	1	`782e0a99824c…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203415-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203415-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203415-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203415-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 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	N203415-001	9126941	2026-05-15	U-2345		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	9126941	2026-05-15	U-1588		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	9126941	2026-05-15	U-2708		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	9126941	2026-05-15	U-3763		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	8183274	2026-08-24	U-1281		2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	8183274	2026-08-24	U-1588		2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	8183274	2026-08-24	U-2708		2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	8183274	2026-08-24	U-2345		2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	8183274	2026-08-24	U-3763		2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	7709517	2027-08-13		Drug substance, Drug product	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	12161628	2037-02-23	U-4101		2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	12161628	2037-02-23	U-4102		2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	12161628	2037-02-23	U-4103		2025-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203415-001	12161628	2037-02-23	U-4104		2025-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	9126941	2026-05-15	U-2345		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	9126941	2026-05-15	U-1588		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	9126941	2026-05-15	U-2708		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	9126941	2026-05-15	U-3763		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	8183274	2026-08-24	U-1281		2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	8183274	2026-08-24	U-1588		2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	8183274	2026-08-24	U-2708		2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	8183274	2026-08-24	U-2345		2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	8183274	2026-08-24	U-3763		2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	7709517	2027-08-13		Drug substance, Drug product	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	12161628	2037-02-23	U-4101		2025-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	12161628	2037-02-23	U-4102		2025-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	12161628	2037-02-23	U-4103		2025-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	12161628	2037-02-23	U-4104		2025-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203415-001	9126941	2026-05-15	U-2345		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	9126941	2026-05-15	U-1588		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	9126941	2026-05-15	U-2708		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	9126941	2026-05-15	U-3763		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	8183274	2026-08-24	U-1281		2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	8183274	2026-08-24	U-1588		2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	8183274	2026-08-24	U-2708		2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	8183274	2026-08-24	U-2345		2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	8183274	2026-08-24	U-3763		2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	7709517	2027-08-13		Drug substance, Drug product	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	12161628	2037-02-23	U-4101		2025-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203415-001	12161628	2037-02-23	U-4102		2025-01-08	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203415-001	I-926	2026-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203415-001	I-926	2026-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203415-001	I-926	2026-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203415-001	I-926	2026-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203415-001	I-926	2026-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203415-001	I-926	2026-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203415-001	I-926	2026-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203415-001	I-926	2026-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203415-001	I-926	2026-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203415-001	I-926	2026-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203415-001	I-926	2026-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203415-001	I-926	2026-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203415-001	I-926	2026-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203415-001	I-926	2026-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203415-001	I-808	2022-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203415-001	I-808	2022-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203415-001	I-808	2022-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203415-001	I-786	2021-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203415-001	I-808	2022-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203415-001	I-786	2021-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203415-001	I-808	2022-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203415-001	I-786	2021-07-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203415-001	I-808	2022-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203415-001	I-786	2021-07-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203415-001	I-808	2022-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203415-001	I-786	2021-07-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203415-001	I-808	2022-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203415-001	I-786	2021-07-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203415-001	I-808	2022-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203415-001	I-786	2021-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203415-001	I-786	2021-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203415-001	I-786	2021-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203415-001	I-926	2026-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203415-001	I-926	2026-11-17	`1c564ffb4f44…`
2023-01-26 05:58 UTC	2023-01	N203415-001	I-808	2022-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203415-001	I-808	2022-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203415-001	I-808	2022-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203415-001	I-808	2022-12-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203415-001	I-808	2022-12-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203415-001	I-926	2026-11-17	`a50c72e98297…`

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
Xtandi	ENZALUTAMIDE	Astellas Pharma US, Inc.	b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203415 application number: NDA203415 ndc (product): 0469-1125 ndc (product): 0469-0125

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-0125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-1125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current
0469-1125	Xtandi	enzalutamide	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84446	SUPPL	2025-12-18
84396	SUPPL	2025-12-12
81709	SUPPL	2025-03-25
81708	SUPPL	2025-03-25
81705	SUPPL	2025-03-24
80925	SUPPL	2025-02-12
81140	SUPPL	2025-02-07
76628	SUPPL	2023-11-17
76593	SUPPL	2023-11-17
72072	SUPPL	2022-09-13
72064	SUPPL	2022-09-12
69923	SUPPL	2022-01-19
69890	SUPPL	2022-01-18
65042	SUPPL	2020-10-27
65032	SUPPL	2020-10-27
61341	SUPPL	2019-12-19
61285	SUPPL	2019-12-16
54897	SUPPL	2018-07-16
54886	SUPPL	2018-07-13
49101	SUPPL	2017-07-27
49082	SUPPL	2017-07-25
45629	SUPPL	2016-10-21
45577	SUPPL	2016-10-20
10214	SUPPL	2015-10-09
19468	SUPPL	2015-10-08
19467	SUPPL	2015-09-21
32422	SUPPL	2015-08-10
40297	SUPPL	2015-07-22
10213	SUPPL	2015-07-22
10212	SUPPL	2014-09-16
40296	SUPPL	2014-09-10
19466	SUPPL	2013-03-26
44882	ORIG	2012-09-12
43431	ORIG	2012-09-12
32421	ORIG	2012-09-05
19465	ORIG	2012-08-31