Application 213535

Type: NDA
Sponsor: GENENTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVRYSDI	RISDIPLAM	POWDER FOR ORAL SOLUTION	1.5MG	No	No

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

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
N213535-001	EVRYSDI	RISDIPLAM	0.75MG/ML	FOR SOLUTION / ORAL		RLD, RS	2020-08-07

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03
N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03
N213535-001	11827646	2036-01-25	U-1943		2023-12-14
N213535-001	11938136	2036-11-08		Drug product	2024-04-17
N213535-001	12350273	2038-10-01	U-1943		2025-07-31
N213535-001	11534444	2038-10-04	U-1943		2023-01-25
N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213535-001	M-270	2026-10-03
N213535-001	ODE-334	2027-08-07
N213535-001	ODE-400	2029-05-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213535-001	EVRYSDI	0.75MG/ML	FOR SOLUTION / ORAL	RLD, RS	2020-08-07	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	12122789	2041-04-15		Drug substance, Drug product	2024-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213535-001	11534444	2038-10-04	U-1943		2023-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213535-001	9586955	2033-02-08		Drug substance, Drug product	2020-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213535-001	9969754	2035-05-11	U-1943	Drug substance, Drug product	2020-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213535-001	11827646	2036-01-25	U-1943		2023-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213535-001	11938136	2036-11-08		Drug product	2024-04-17	`d06236e962d9…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N213535-001	M-270	2026-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213535-001	ODE-334	2027-08-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213535-001	ODE-400	2029-05-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213535-001	M-270	2026-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213535-001	ODE-334	2027-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213535-001	ODE-400	2029-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213535-001	M-270	2026-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213535-001	ODE-334	2027-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213535-001	ODE-400	2029-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213535-001	M-270	2026-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213535-001	ODE-334	2027-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213535-001	ODE-400	2029-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	NPP	2025-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	NCE	2025-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	M-270	2026-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	ODE-334	2027-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213535-001	ODE-400	2029-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213535-001	NPP	2025-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213535-001	NCE	2025-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213535-001	M-270	2026-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213535-001	ODE-334	2027-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213535-001	ODE-400	2029-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	NPP	2025-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	NCE	2025-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	M-270	2026-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	ODE-334	2027-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213535-001	ODE-400	2029-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	NPP	2025-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	NCE	2025-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	M-270	2026-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	ODE-334	2027-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213535-001	ODE-400	2029-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	NPP	2025-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	NCE	2025-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	M-270	2026-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	ODE-334	2027-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213535-001	ODE-400	2029-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	NPP	2025-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	NCE	2025-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213535-001	M-270	2026-10-03	`2680178bc6a6…`

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current
50242-175	EVRYSDI	Risdiplam	Genentech Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85090	SUPPL	2026-02-20
85089	SUPPL	2026-02-20
84841	SUPPL	2026-01-27
84821	SUPPL	2026-01-22
81248	SUPPL	2025-02-14
81229	SUPPL	2025-02-12
79658	SUPPL	2024-09-19
79649	SUPPL	2024-09-18
77684	SUPPL	2024-03-01
77679	SUPPL	2024-03-01
75674	SUPPL	2023-10-05
73877	SUPPL	2023-03-27
73871	SUPPL	2023-03-27
72151	SUPPL	2022-09-23
72138	SUPPL	2022-09-22
71196	SUPPL	2022-06-01
71195	SUPPL	2022-06-01
71175	SUPPL	2022-05-31
71174	SUPPL	2022-05-31
67406	SUPPL	2021-05-05
67396	SUPPL	2021-05-04
64492	ORIG	2020-09-04
64248	ORIG	2020-08-10
64246	ORIG	2020-08-03