Application 202611

Type: NDA
Sponsor: APGDI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYRBETRIQ	MIRABEGRON	TABLET, EXTENDED RELEASE;ORAL	25MG	Yes	Yes
002	MYRBETRIQ	MIRABEGRON	TABLET, EXTENDED RELEASE;ORAL	50MG	Yes	Yes

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

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
N202611-001	MYRBETRIQ	MIRABEGRON	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28
N202611-002	MYRBETRIQ	MIRABEGRON	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N202611-001	AB
N202611-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 26 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202611-001	8772315	2028-10-30	U-2300		2018-05-17
N202611-001	8772315*PED	2029-04-30		Pediatric extension
N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11
N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11
N202611-001	11707451	2029-09-28	U-2996		2023-08-21
N202611-001	11707451	2029-09-28	U-3670		2023-08-21
N202611-001	12059409	2029-09-28		Drug product	2024-08-28
N202611-001	12097189	2029-09-28	U-2996		2024-10-02
N202611-001	12097189	2029-09-28	U-3670		2024-10-02
N202611-001	10842780*PED	2030-03-28		Pediatric extension
N202611-001	11707451*PED	2030-03-28		Pediatric extension
N202611-001	12059409*PED	2030-03-28		Pediatric extension
N202611-001	12097189*PED	2030-03-28		Pediatric extension
N202611-002	8772315	2028-10-30	U-2300		2018-05-17
N202611-002	8772315*PED	2029-04-30		Pediatric extension
N202611-002	10842780	2029-09-28	U-2996	Drug product	2020-12-11
N202611-002	10842780	2029-09-28	U-3670	Drug product	2020-12-11
N202611-002	11707451	2029-09-28	U-2996		2023-08-21
N202611-002	11707451	2029-09-28	U-3670		2023-08-21
N202611-002	12059409	2029-09-28		Drug product	2024-08-28
N202611-002	12097189	2029-09-28	U-2996		2024-10-02
N202611-002	12097189	2029-09-28	U-3670		2024-10-02
N202611-002	10842780*PED	2030-03-28		Pediatric extension
N202611-002	11707451*PED	2030-03-28		Pediatric extension
N202611-002	12059409*PED	2030-03-28		Pediatric extension
N202611-002	12097189*PED	2030-03-28		Pediatric extension

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202611-001	MYRBETRIQ	25MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202611-002	MYRBETRIQ	50MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2012-06-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202611-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202611-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202611-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202611-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202611-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202611-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202611-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202611-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202611-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202611-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N202611-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202611-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202611-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202611-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202611-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202611-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202611-002	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,012 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	N202611-001	8772315	2028-10-30	U-2300		2018-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	8772315*PED	2029-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451	2029-09-28	U-2996		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451	2029-09-28	U-3670		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12059409	2029-09-28		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189	2029-09-28	U-2996		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189	2029-09-28	U-3670		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	10842780*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	11707451*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12059409*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-001	12097189*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	8772315	2028-10-30	U-2300		2018-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	8772315*PED	2029-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451	2029-09-28	U-2996		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451	2029-09-28	U-3670		2023-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12059409	2029-09-28		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189	2029-09-28	U-2996		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189	2029-09-28	U-3670		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	10842780*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	11707451*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12059409*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202611-002	12097189*PED	2030-03-28		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	8772315	2028-10-30	U-2300		2018-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	8772315*PED	2029-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780	2029-09-28	U-3670	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780	2029-09-28	U-2996	Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451	2029-09-28	U-2996		2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451	2029-09-28	U-3670		2023-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12059409	2029-09-28		Drug product	2024-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189	2029-09-28	U-2996		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189	2029-09-28	U-3670		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	10842780*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	11707451*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12059409*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-001	12097189*PED	2030-03-28		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202611-002	8772315	2028-10-30	U-2300		2018-05-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	I-855	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-001	PED	2024-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	I-855	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202611-002	PED	2024-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	I-855	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-001	PED	2024-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	I-855	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202611-002	PED	2024-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	I-855	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-001	PED	2024-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	I-855	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202611-002	PED	2024-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	I-855	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-001	PED	2024-09-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	I-855	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202611-002	PED	2024-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202611-001	I-855	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-001	PED	2024-09-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	I-855	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202611-002	PED	2024-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	I-855	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-001	PED	2024-09-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	I-855	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202611-002	PED	2024-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	I-855	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-001	PED	2024-09-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	I-855	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202611-002	PED	2024-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	I-855	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-001	PED	2024-09-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	I-855	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202611-002	PED	2024-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202611-001	I-855	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-001	PED	2024-09-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	I-855	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202611-002	PED	2024-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	I-855	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-001	PED	2024-09-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	I-855	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202611-002	PED	2024-09-25	`5c6f7cd8ea54…`

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
Myrbetriq	MIRABEGRON	Astellas Pharma US, Inc.	ba9e9e15-e666-4c56-9271-2e24739cfa2d	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202611 application number: NDA202611 ndc (product): 0469-2601 ndc (product): 0469-2602

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2601	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-2602	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
55154-8712	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8712	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8712	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8712	Myrbetriq	mirabegron	Cardinal Health 107, LLC	NDA	Current
55154-8713	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8713	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8713	Myrbetriq	mirabegron	Cardinal Health	NDA	Current
55154-8713	Myrbetriq	mirabegron	Cardinal Health 107, LLC	NDA	Current
70518-2435	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-2435	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-2435	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-2435	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-3158	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-3158	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current
70518-3158	Myrbetriq	mirabegron	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66915	SUPPL	2021-03-30
66894	SUPPL	2021-03-26
54035	SUPPL	2018-05-07
53986	SUPPL	2018-05-03
49193	SUPPL	2017-08-02
49163	SUPPL	2017-07-31
45082	SUPPL	2016-08-17
45129	SUPPL	2016-08-16
32286	SUPPL	2015-11-04
19363	SUPPL	2015-11-04
19364	SUPPL	2015-08-11
10086	SUPPL	2015-08-11
22893	ORIG	2012-08-10
40205	ORIG	2012-06-28
32285	ORIG	2012-06-28