Application 213026

Type: NDA
Sponsor: SAREPTA THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMONDYS 45	CASIMERSEN	SOLUTION;INTRAVENOUS	100 mg/2 mL/VIAL	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N213026-001	AMONDYS 45	CASIMERSEN	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2021-02-25

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
N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31
N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31
N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23
N213026-001	10781450	2030-11-12	U-3089		2021-03-23
N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23
N213026-001	9758783	2030-11-12	U-3088		2021-03-23
N213026-001	9758783	2030-11-12	U-3089		2021-03-23

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213026-001	NCE	2026-02-25
N213026-001	ODE-347	2028-02-25

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
2026-09-14 22:38:34	2026-08	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213026-001	AMONDYS 45	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 288 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	10781450	2030-11-12	U-3089		2021-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	9758783	2030-11-12	U-3088		2021-03-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	9758783	2030-11-12	U-3089		2021-03-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	10781450	2030-11-12	U-3089		2021-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	9758783	2030-11-12	U-3088		2021-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	9758783	2030-11-12	U-3089		2021-03-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	10781450	2030-11-12	U-3089		2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	9758783	2030-11-12	U-3088		2021-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	9758783	2030-11-12	U-3089		2021-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	9447415	2025-06-28		Drug substance, Drug product	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	10781450	2030-11-12	U-3089		2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	9758783	2030-11-12	U-3088		2021-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	9758783	2030-11-12	U-3089		2021-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213026-001	9447415	2025-06-28		Drug substance, Drug product	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	RE48960	2029-02-16	U-3087	Drug substance, Drug product	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	RE48960	2029-02-16	U-3088	Drug substance, Drug product	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	10287586	2030-11-12		Drug substance, Drug product	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	10781450	2030-11-12	U-3089		2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	9228187	2030-11-12		Drug substance, Drug product	2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	9758783	2030-11-12	U-3088		2021-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	9758783	2030-11-12	U-3089		2021-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	9447415	2025-06-28		Drug substance, Drug product	2021-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	RE48960	2025-06-28	U-3087	Drug substance, Drug product	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	RE48960	2025-06-28	U-3088	Drug substance, Drug product	2022-03-31	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 71 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213026-001	NCE	2026-02-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213026-001	ODE-347	2028-02-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213026-001	NCE	2026-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213026-001	ODE-347	2028-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213026-001	NCE	2026-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213026-001	ODE-347	2028-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	NCE	2026-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213026-001	ODE-347	2028-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213026-001	NCE	2026-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213026-001	ODE-347	2028-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	NCE	2026-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213026-001	ODE-347	2028-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213026-001	NCE	2026-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213026-001	ODE-347	2028-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213026-001	NCE	2026-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213026-001	ODE-347	2028-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213026-001	NCE	2026-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213026-001	ODE-347	2028-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213026-001	NCE	2026-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213026-001	ODE-347	2028-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213026-001	NCE	2026-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213026-001	ODE-347	2028-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213026-001	NCE	2026-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213026-001	ODE-347	2028-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213026-001	NCE	2026-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213026-001	ODE-347	2028-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213026-001	NCE	2026-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213026-001	ODE-347	2028-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213026-001	NCE	2026-02-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213026-001	ODE-347	2028-02-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213026-001	NCE	2026-02-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213026-001	ODE-347	2028-02-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213026-001	NCE	2026-02-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213026-001	ODE-347	2028-02-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213026-001	NCE	2026-02-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213026-001	ODE-347	2028-02-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213026-001	NCE	2026-02-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213026-001	ODE-347	2028-02-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213026-001	NCE	2026-02-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213026-001	ODE-347	2028-02-25	`bb7c543d1eb4…`

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
AMONDYS 45	CASIMERSEN	Sarepta Therapeutics, Inc.	e9e5fd44-eeda-4580-bba1-a734828bbcc3	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213026 application number: NDA213026 ndc (product): 60923-227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60923-227	AMONDYS 45	casimersen	Sarepta Therapeutics, Inc.	NDA	Current
60923-227	AMONDYS 45	casimersen	Sarepta Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84718	SUPPL	2026-01-08
79084	SUPPL	2024-07-15
79069	SUPPL	2024-07-15
73860	SUPPL	2023-03-24
73857	SUPPL	2023-03-24
66805	ORIG	2021-03-18
66413	ORIG	2021-03-01
66411	ORIG	2021-02-26