Application 210951

Type: NDA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERLEADA	APALUTAMIDE	TABLET;ORAL	60MG	Yes	Yes
002	ERLEADA	APALUTAMIDE	TABLET;ORAL	240MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210951-001	ERLEADA	APALUTAMIDE	60MG	TABLET / ORAL	AB	RLD	2018-02-14
N210951-002	ERLEADA	APALUTAMIDE	240MG	TABLET / ORAL		RLD, RS	2023-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N210951-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 36 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210951-001	8802689	2027-03-27	U-2237		2018-03-05
N210951-001	8802689	2027-03-27	U-2624		2018-03-05
N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05
N210951-001	9987261	2027-03-27		Drug product	2018-10-18
N210951-001	8445507	2032-02-14	U-2237	Drug substance, Drug product	2018-03-05
N210951-001	8445507	2032-02-14	U-2624	Drug substance, Drug product	2018-03-05
N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05
N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05
N210951-001	10849888	2033-09-23	U-3013		2021-01-05
N210951-001	9884054	2033-09-23	U-2237		2018-03-05
N210951-001	RE49353	2033-09-23	U-2381		2023-01-12
N210951-001	RE50642	2033-09-23	U-4450		2026-04-02
N210951-001	12303493	2035-12-03		Drug product	2025-06-16
N210951-001	10702508	2038-04-30	U-3012		2021-01-05
N210951-001	11963952	2040-01-30	U-3901		2024-04-26
N210951-001	12303497	2040-01-30	U-4448		2025-06-16
N210951-001	12303497	2040-01-30	U-4494		2025-06-16
N210951-001	11723898	2041-01-14	U-4449		2026-04-02
N210951-002	8802689	2027-03-27	U-2237		2023-02-27
N210951-002	8802689	2027-03-27	U-2624		2023-02-27
N210951-002	9388159	2027-03-27		Drug substance, Drug product	2023-02-27
N210951-002	9987261	2027-03-27		Drug product	2023-02-27
N210951-002	8445507	2032-02-14	U-2237	Drug substance, Drug product	2023-02-27
N210951-002	8445507	2032-02-14	U-2624	Drug substance, Drug product	2023-02-27
N210951-002	9481663	2033-06-04	U-2237	Drug substance, Drug product	2023-02-27
N210951-002	9481663	2033-06-04	U-2624	Drug substance, Drug product	2023-02-27
N210951-002	10849888	2033-09-23	U-3013		2023-02-27
N210951-002	9884054	2033-09-23	U-2237		2023-02-27
N210951-002	RE49353	2033-09-23	U-2381		2023-02-27
N210951-002	RE50642	2033-09-23	U-4450		2026-04-02
N210951-002	12303493	2035-12-03		Drug product	2025-06-16
N210951-002	10702508	2038-04-30	U-3012		2023-02-27
N210951-002	11963952	2040-01-30	U-3901		2024-04-26
N210951-002	12303497	2040-01-30	U-4448		2025-06-16
N210951-002	12303497	2040-01-30	U-4494		2025-06-16
N210951-002	11723898	2041-01-14	U-4449		2026-04-02

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 · 70 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
2026-10-15 13:18:30	2026-09	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210951-001	ERLEADA	60MG	TABLET / ORAL	AB	RLD	2018-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD	2018-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210951-002	ERLEADA	240MG	TABLET / ORAL		RLD, RS	2023-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210951-001	ERLEADA	60MG	TABLET / ORAL		RLD, RS	2018-02-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N210951-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210951-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210951-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210951-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210951-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210951-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210951-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 9 of 25 · 964 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	9987261	2027-03-27		Drug product	2018-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	8445507	2030-09-15	U-2624	Drug substance, Drug product	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	8445507	2030-09-15	U-2237	Drug substance, Drug product	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	10052314	2033-09-23	U-2381	Delist requested	2018-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	10052314	2033-09-23	U-2382	Delist requested	2018-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	10849888	2033-09-23	U-3013		2021-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	9884054	2033-09-23	U-2237		2018-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	RE49353	2033-09-23	U-2381		2023-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	10702508	2038-04-30	U-3012		2021-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-001	11963952	2040-01-30	U-3901		2024-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	8802689	2027-03-27	U-2237		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	8802689	2027-03-27	U-2624		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	9388159	2027-03-27		Drug substance, Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	9987261	2027-03-27		Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	8445507	2030-09-15	U-2237	Drug substance, Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	8445507	2030-09-15	U-2624	Drug substance, Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	9481663	2033-06-04	U-2624	Drug substance, Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	9481663	2033-06-04	U-2237	Drug substance, Drug product	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	10849888	2033-09-23	U-3013		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	9884054	2033-09-23	U-2237		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	RE49353	2033-09-23	U-2381		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	10702508	2038-04-30	U-3012		2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210951-002	11963952	2040-01-30	U-3901		2024-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	8802689	2027-03-27	U-2237		2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	8802689	2027-03-27	U-2624		2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	9388159	2027-03-27		Drug substance, Drug product	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	9987261	2027-03-27		Drug product	2018-10-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	8445507	2030-09-15	U-2624	Drug substance, Drug product	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	8445507	2030-09-15	U-2237	Drug substance, Drug product	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	9481663	2033-06-04	U-2624	Drug substance, Drug product	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	9481663	2033-06-04	U-2237	Drug substance, Drug product	2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	10052314	2033-09-23	U-2381	Delist requested	2018-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	10052314	2033-09-23	U-2382	Delist requested	2018-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	10849888	2033-09-23	U-3013		2021-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	9884054	2033-09-23	U-2237		2018-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	RE49353	2033-09-23	U-2381		2023-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210951-001	10702508	2038-04-30	U-3012		2021-01-05	`d8e5a09893c0…`

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	N210951-001	I-808	2022-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210951-001	NCE	2023-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210951-001	I-808	2022-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210951-001	NCE	2023-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210951-001	I-808	2022-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210951-001	NCE	2023-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210951-001	I-808	2022-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210951-001	NCE	2023-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210951-001	I-808	2022-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210951-001	NCE	2023-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210951-001	I-808	2022-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210951-001	NCE	2023-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210951-001	I-808	2022-09-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210951-001	NCE	2023-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210951-001	I-808	2022-09-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210951-001	NCE	2023-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210951-001	I-808	2022-09-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210951-001	NCE	2023-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210951-001	I-808	2022-09-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210951-001	NCE	2023-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210951-001	I-808	2022-09-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210951-001	NCE	2023-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210951-001	NCE	2023-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210951-001	NCE	2023-02-14	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N210951-001	NCE	2023-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210951-001	NCE	2023-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210951-001	NCE	2023-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210951-001	NCE	2023-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210951-001	NCE	2023-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210951-001	NCE	2023-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210951-001	I-808	2022-09-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N210951-001	NCE	2023-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210951-001	I-808	2022-09-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210951-001	NCE	2023-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210951-001	I-808	2022-09-17	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N210951-001	NCE	2023-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210951-001	I-808	2022-09-17	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N210951-001	NCE	2023-02-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210951-001	I-808	2022-09-17	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210951-001	NCE	2023-02-14	`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
ERLEADA	APALUTAMIDE	Janssen Products, LP	d1cda4f7-cb33-46ea-b9ac-431f6452b1a5	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210951 application number: NDA210951 ndc (product): 59676-600

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current
59676-600	ERLEADA	Apalutamide	Janssen Products, LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85346	SUPPL	2026-03-12
85291	SUPPL	2026-03-09
79330	SUPPL	2024-08-08
79312	SUPPL	2024-08-05
79051	SUPPL	2024-07-12
79031	SUPPL	2024-07-10
77093	SUPPL	2023-12-20
77091	SUPPL	2023-12-20
73577	SUPPL	2023-03-01
73556	SUPPL	2023-02-17
72591	SUPPL	2022-11-10
72590	SUPPL	2022-11-10
72586	SUPPL	2022-11-09
72585	SUPPL	2022-11-09
70819	SUPPL	2022-04-27
70816	SUPPL	2022-04-26
68575	SUPPL	2021-09-10
68558	SUPPL	2021-09-08
68105	SUPPL	2021-07-16
68093	SUPPL	2021-07-15
65312	SUPPL	2020-11-25
65299	SUPPL	2020-11-23
64498	SUPPL	2020-09-04
64475	SUPPL	2020-09-02
63888	SUPPL	2020-07-14
63857	SUPPL	2020-07-13
60034	SUPPL	2019-09-18
60027	SUPPL	2019-09-17
53051	ORIG	2018-03-19
52643	ORIG	2018-02-14
52629	ORIG	2018-02-14