Application 209531

Type: NDA
Sponsor: BIOGEN IDEC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPINRAZA	NUSINERSEN SODIUM	SOLUTION;INTRATHECAL	12MG/5ML (2.4MG/ML)	Yes	Yes
002	SPINRAZA	NUSINERSEN SODIUM	SOLUTION;INTRATHECAL	EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)	Yes	Yes
003	SPINRAZA	NUSINERSEN SODIUM	SOLUTION;INTRATHECAL	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209531-001	SPINRAZA	NUSINERSEN SODIUM	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23
N209531-002	SPINRAZA	NUSINERSEN SODIUM	EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2026-03-27
N209531-003	SPINRAZA	NUSINERSEN SODIUM	EQ 50MG BASE/5ML (EQ 10MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2026-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209531-001	7838657	2027-07-11		Drug substance	2017-01-23
N209531-001	9717750	2030-06-17	U-1942		2017-08-31
N209531-001	9717750	2030-06-17	U-1943		2017-08-31
N209531-001	9717750	2030-06-17	U-2093		2017-08-31
N209531-001	9717750	2030-06-17	U-2094		2017-08-31
N209531-001	8980853	2030-11-24	U-1941		2017-01-23
N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23
N209531-001	9926559	2034-01-09	U-1943		2018-04-24
N209531-001	10436802	2035-09-11	U-1941		2019-10-17
N209531-001	10436802	2035-09-11	U-1942		2019-10-17
N209531-001	10436802	2035-09-11	U-1943		2019-10-17
N209531-001	10436802	2035-09-11	U-1944		2019-10-17
N209531-001	10436802	2035-09-11	U-2093		2019-10-17
N209531-001	10436802	2035-09-11	U-2094		2019-10-17
N209531-001	12013403	2036-03-04	U-1941		2024-06-28
N209531-001	12013403	2036-03-04	U-1942		2024-06-28
N209531-001	12013403	2036-03-04	U-1943		2024-06-28
N209531-001	12013403	2036-03-04	U-1944		2024-06-28
N209531-001	12013403	2036-03-04	U-2093		2024-06-28
N209531-001	12013403	2036-03-04	U-2094		2024-06-28
N209531-002	7838657	2027-07-11		Drug substance, Drug product	2026-04-20
N209531-002	9717750	2030-06-17	U-1942		2026-04-20
N209531-002	9717750	2030-06-17	U-1943		2026-04-20
N209531-002	9717750	2030-06-17	U-2093		2026-04-20
N209531-002	9717750	2030-06-17	U-2094		2026-04-20
N209531-002	8980853	2030-11-24	U-1941		2026-04-20
N209531-002	8361977	2030-12-23		Drug substance, Drug product	2026-04-20
N209531-003	7838657	2027-07-11		Drug substance, Drug product	2026-04-20
N209531-003	9717750	2030-06-17	U-1942		2026-04-20
N209531-003	9717750	2030-06-17	U-1943		2026-04-20
N209531-003	9717750	2030-06-17	U-2093		2026-04-20
N209531-003	9717750	2030-06-17	U-2094		2026-04-20
N209531-003	8980853	2030-11-24	U-1941		2026-04-20
N209531-003	8361977	2030-12-23		Drug substance, Drug product	2026-04-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209531-002	NS	2029-03-27
N209531-003	NS	2029-03-27

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 · 43 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	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209531-001	SPINRAZA	12MG/5ML (2.4MG/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209531-001	SPINRAZA	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION / INTRATHECAL	RLD, RS	2016-12-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 909 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	N209531-001	7838657	2027-07-11		Drug substance	2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-1942		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-2094		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-2093		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9717750	2030-06-17	U-1943		2017-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	8980853	2030-11-24	U-1941		2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	9926559	2034-01-09	U-1943		2018-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-2094		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1943		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1941		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-2093		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1944		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	10436802	2035-09-11	U-1942		2019-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1941		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1942		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1943		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-1944		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-2093		2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209531-001	12013403	2036-03-04	U-2094		2024-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1944		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1942		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10266822	2025-12-05	U-1943		2019-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1943		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1944		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8110560	2025-12-05	U-1942		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	7838657	2027-07-11		Drug substance	2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-1942		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-2094		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-2093		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9717750	2030-06-17	U-1943		2017-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8980853	2030-11-24	U-1941		2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	8361977	2030-12-23		Drug substance, Drug product	2017-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	9926559	2034-01-09	U-1943		2018-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-2094		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1943		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1941		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-2093		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1944		2019-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209531-001	10436802	2035-09-11	U-1942		2019-10-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

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	N209531-001	ODE-127	2023-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209531-001	ODE-127	2023-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209531-001	ODE-127	2023-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209531-001	M-226	2021-05-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209531-001	NCE	2021-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209531-001	ODE-127	2023-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209531-001	ODE-127	2023-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209531-001	M-226	2021-05-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209531-001	NCE	2021-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209531-001	ODE-127	2023-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	M-226	2021-05-14	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	NCE	2021-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209531-001	ODE-127	2023-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209531-001	M-226	2021-05-14	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209531-001	NCE	2021-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209531-001	ODE-127	2023-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209531-001	M-226	2021-05-14	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209531-001	NCE	2021-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209531-001	ODE-127	2023-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209531-001	M-226	2021-05-14	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209531-001	NCE	2021-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209531-001	ODE-127	2023-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209531-001	M-226	2021-05-14	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209531-001	NCE	2021-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209531-001	ODE-127	2023-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209531-001	M-226	2021-05-14	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209531-001	NCE	2021-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209531-001	ODE-127	2023-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209531-001	M-226	2021-05-14	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209531-001	NCE	2021-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209531-001	ODE-127	2023-12-23	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N209531-001	ODE-127	2023-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209531-001	ODE-127	2023-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209531-001	ODE-127	2023-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209531-001	ODE-127	2023-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209531-001	ODE-127	2023-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209531-001	ODE-127	2023-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209531-001	ODE-127	2023-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209531-001	ODE-127	2023-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209531-001	ODE-127	2023-12-23	`f41ea6bd6efb…`

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
Spinraza	NUSINERSEN	Biogen Inc.	dd70cd5f-b0fc-4ba4-a5ea-89a34778bd94	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209531 application number: NDA209531 ndc (product): 64406-058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64406-058	Spinraza	Nusinersen	Biogen	NDA	Current
64406-058	Spinraza	Nusinersen	Biogen	NDA	Current
64406-058	Spinraza	Nusinersen	Biogen	NDA	Current
64406-058	Spinraza	Nusinersen	Biogen	NDA	Current
64406-058	Spinraza	Nusinersen	Biogen	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85598	SUPPL	2026-03-31
85572	SUPPL	2026-03-30
78117	SUPPL	2024-04-12
78116	SUPPL	2024-04-12
78115	SUPPL	2024-04-12
78114	SUPPL	2024-04-12
73583	SUPPL	2023-02-21
73569	SUPPL	2023-02-21
63606	SUPPL	2020-06-17
63598	SUPPL	2020-06-17
59150	SUPPL	2019-06-21
59149	SUPPL	2019-06-21
59115	SUPPL	2019-06-18
59116	SUPPL	2019-06-17
55938	SUPPL	2018-10-15
55896	SUPPL	2018-10-11
54237	SUPPL	2018-05-17
54236	SUPPL	2018-05-17
54215	SUPPL	2018-05-16
54214	SUPPL	2018-05-16
50496	SUPPL	2017-11-27
50472	SUPPL	2017-11-22
46895	ORIG	2017-01-18
46518	ORIG	2016-12-23
46517	ORIG	2016-12-23