Application 206488

Type: NDA
Sponsor: SAREPTA THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXONDYS 51	ETEPLIRSEN	SOLUTION;INTRAVENOUS	100MG/2ML (50MG/ML)	Yes	Yes
002	EXONDYS 51	ETEPLIRSEN	SOLUTION;INTRAVENOUS	500MG/10ML (50MG/ML)	Yes	Yes

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

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
N206488-001	EXONDYS 51	ETEPLIRSEN	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-09-19
N206488-002	EXONDYS 51	ETEPLIRSEN	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2016-09-19

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206488-001	RE48468	2028-10-27	U-2097		2021-04-12
N206488-001	RE47769	2029-02-02		Drug product	2019-12-18
N206488-001	10337003	2034-03-14	U-1918		2019-09-10
N206488-001	10364431	2034-03-14	U-1918		2019-08-28
N206488-001	10364431	2034-03-14	U-1919		2019-08-28
N206488-001	9506058	2034-03-14	U-1918		2016-12-01
N206488-001	9506058	2034-03-14	U-1919		2016-12-01
N206488-002	RE48468	2028-10-27	U-2097		2021-04-12
N206488-002	RE47769	2029-02-02		Drug product	2019-12-18
N206488-002	10337003	2034-03-14	U-1918		2019-09-10
N206488-002	10364431	2034-03-14	U-1918		2019-08-28
N206488-002	10364431	2034-03-14	U-1919		2019-08-28
N206488-002	9506058	2034-03-14	U-1918		2016-12-01
N206488-002	9506058	2034-03-14	U-1919		2016-12-01

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206488-001	EXONDYS 51	100MG/2ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	EXONDYS 51	500MG/10ML (50MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2016-09-19	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 30 · 1,188 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	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	9506058	2034-03-14	U-1918		2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206488-002	9506058	2034-03-14	U-1919		2016-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	9506058	2034-03-14	U-1918		2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206488-002	9506058	2034-03-14	U-1919		2016-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206488-001	RE48468	2028-10-27	U-2097		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	RE47769	2029-02-02		Drug product	2019-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10337003	2034-03-14	U-1918		2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10364431	2034-03-14	U-1919		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	10364431	2034-03-14	U-1918		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	9506058	2034-03-14	U-1918		2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-001	9506058	2034-03-14	U-1919		2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	RE48468	2028-10-27	U-2097		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	RE47769	2029-02-02		Drug product	2019-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10337003	2034-03-14	U-1918		2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10364431	2034-03-14	U-1919		2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206488-002	10364431	2034-03-14	U-1918		2019-08-28	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 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	N206488-001	ODE-122	2023-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206488-002	ODE-122	2023-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206488-001	ODE-122	2023-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206488-002	ODE-122	2023-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206488-001	ODE-122	2023-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206488-002	ODE-122	2023-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206488-001	NCE	2021-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-001	ODE-122	2023-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	NCE	2021-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206488-002	ODE-122	2023-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206488-001	ODE-122	2023-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206488-002	ODE-122	2023-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206488-001	NCE	2021-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-001	ODE-122	2023-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-002	NCE	2021-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206488-002	ODE-122	2023-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-001	NCE	2021-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-001	ODE-122	2023-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-002	NCE	2021-09-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206488-002	ODE-122	2023-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206488-001	NCE	2021-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-001	ODE-122	2023-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-002	NCE	2021-09-19	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206488-002	ODE-122	2023-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206488-001	NCE	2021-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-001	ODE-122	2023-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-002	NCE	2021-09-19	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206488-002	ODE-122	2023-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206488-001	NCE	2021-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-001	ODE-122	2023-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-002	NCE	2021-09-19	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206488-002	ODE-122	2023-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206488-001	NCE	2021-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-001	ODE-122	2023-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-002	NCE	2021-09-19	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206488-002	ODE-122	2023-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206488-001	NCE	2021-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-001	ODE-122	2023-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-002	NCE	2021-09-19	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206488-002	ODE-122	2023-09-19	`b00525d2431f…`

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
Exondys 51	ETEPLIRSEN	Sarepta Therapeutics, Inc.	33bff678-7829-479e-9110-b8e33a0bc0aa	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206488 application number: NDA206488 ndc (product): 60923-363 ndc (product): 60923-284

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-284	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current
60923-363	Exondys 51	eteplirsen	Sarepta Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80784	SUPPL	2024-12-30
80782	SUPPL	2024-12-30
69927	SUPPL	2022-01-19
69926	SUPPL	2022-01-19
69925	SUPPL	2022-01-19
69906	SUPPL	2022-01-19
69905	SUPPL	2022-01-19
69904	SUPPL	2022-01-19
63839	SUPPL	2020-07-09
63824	SUPPL	2020-07-08
55942	SUPPL	2018-10-15
55898	SUPPL	2018-10-12
54298	SUPPL	2018-05-22
52544	SUPPL	2018-02-09
52524	SUPPL	2018-02-09
45640	ORIG	2016-10-26
45367	ORIG	2016-09-19
45366	ORIG	2016-09-19
45365	ORIG	2016-09-19