Application 212099

Type: NDA
Sponsor: BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUBEQA	DAROLUTAMIDE	TABLET;ORAL	300MG	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
N212099-001	NUBEQA	DAROLUTAMIDE	300MG	TABLET / ORAL		RLD, RS	2019-07-30

Orange Book patents#

Current patent rows page 1 of 1 · 17 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11
N212099-001	11046713	2030-10-27		Drug substance	2021-07-28
N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27
N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27
N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27
N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27
N212099-001	10010530	2036-01-28		Drug substance	2019-08-27
N212099-001	10383853	2036-01-28		Drug substance	2019-08-27
N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11
N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11
N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27
N212099-001	12611397	2040-07-02		Drug product	2026-05-15
N212099-001	12329742	2042-06-17		Drug product	2025-07-02

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212099-001	I-971	2028-06-03

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.

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	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212099-001	NUBEQA	300MG	TABLET / ORAL	RLD, RS	2019-07-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 330 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	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10010530	2036-01-28		Drug substance	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10383853	2036-01-28		Drug substance	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212099-001	12329742	2042-06-17		Drug product	2025-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10010530	2036-01-28		Drug substance	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10383853	2036-01-28		Drug substance	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10835515	2036-01-28	U-4210	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10835515	2036-01-28	U-4208	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10835515	2036-01-28	U-4209	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	10835515	2036-01-28	U-2605	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	11168058	2038-02-27		Drug substance, Drug product	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	12329742	2042-05-14		Drug product	2025-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212099-001	10711013	2030-10-27		Drug substance, Drug product	2020-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	11046713	2030-10-27		Drug substance	2021-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	9657003	2030-10-27	U-4209	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	9657003	2030-10-27	U-4208	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	9657003	2030-10-27	U-4210	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	8975254	2033-03-25	U-4208	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	8975254	2033-03-25	U-4210	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212099-001	8975254	2033-03-25	U-4209	Drug substance, Drug product	2019-08-27	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212099-001	I-971	2028-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	I-900	2025-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212099-001	I-971	2028-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212099-001	I-900	2025-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212099-001	I-900	2025-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212099-001	I-900	2025-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212099-001	NCE	2024-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212099-001	I-900	2025-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212099-001	NCE	2024-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212099-001	I-900	2025-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212099-001	NCE	2024-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212099-001	I-900	2025-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212099-001	NCE	2024-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212099-001	I-900	2025-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212099-001	NCE	2024-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212099-001	I-900	2025-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212099-001	NCE	2024-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212099-001	I-900	2025-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212099-001	NCE	2024-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212099-001	I-900	2025-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212099-001	NCE	2024-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212099-001	I-900	2025-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212099-001	NCE	2024-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212099-001	I-900	2025-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212099-001	NCE	2024-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212099-001	NCE	2024-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212099-001	NCE	2024-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212099-001	NCE	2024-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212099-001	NCE	2024-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212099-001	NCE	2024-07-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212099-001	NCE	2024-07-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212099-001	NCE	2024-07-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212099-001	NCE	2024-07-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212099-001	NCE	2024-07-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212099-001	NCE	2024-07-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N212099-001	NCE	2024-07-30	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212099-001	NCE	2024-07-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212099-001	I-900	2025-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212099-001	NCE	2024-07-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N212099-001	I-900	2025-08-05	`1c564ffb4f44…`

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
NUBEQA	DAROLUTAMIDE	Bayer HealthCare Pharmaceuticals Inc.	1a7cb212-56e4-4b9d-a73d-bfee7fe4735e	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212099 application number: NDA212099 ndc (product): 50419-395

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-395	NUBEQA	darolutamide	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82460	SUPPL	2025-06-05
82466	SUPPL	2025-06-04
75780	SUPPL	2023-10-16
75732	SUPPL	2023-10-16
71775	SUPPL	2022-08-11
71739	SUPPL	2022-08-08
65873	SUPPL	2021-01-08
65871	SUPPL	2021-01-08
59870	ORIG	2019-08-29
59521	ORIG	2019-07-31
59518	ORIG	2019-07-31