Application 213801

Type: NDA
Sponsor: ASTELLAS PHARMA GLOBAL DEV INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYRBETRIQ	MIRABEGRON	SUSPENSION;ORAL	8MG/ML	Yes	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
N213801-001	MYRBETRIQ GRANULES	MIRABEGRON	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N213801-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22
N213801-001	10058536*PED	2036-09-30		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.

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
2026-10-15 13:18:30	2026-09	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD, RS	2021-03-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213801-001	MYRBETRIQ GRANULES	8MG/ML	FOR SUSPENSION, EXTENDED RELEASE / ORAL	AB	RLD, RS	2021-03-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N213801-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213801-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213801-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213801-001	AB	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213801-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 4 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	7342117	2023-11-04		Drug substance	2021-04-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	7982049	2023-11-04		Drug product	2021-04-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213801-001	7342117	2023-11-04		Drug substance	2021-04-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213801-001	7982049	2023-11-04		Drug product	2021-04-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213801-001	6346532	2022-03-27		Drug substance	2021-04-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	6346532*PED	2022-09-27		Pediatric extension		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	7342117	2023-11-04		Drug substance	2021-04-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	7982049	2023-11-04		Drug product	2021-04-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	6346532	2022-03-27		Drug substance	2021-04-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	6346532*PED	2022-09-27		Pediatric extension		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	7342117	2023-11-04		Drug substance	2021-04-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	7982049	2023-11-04		Drug product	2021-04-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213801-001	6346532	2022-03-27		Drug substance	2021-04-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	6346532*PED	2022-09-27		Pediatric extension		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	7342117	2023-11-04		Drug substance	2021-04-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	7982049	2023-11-04		Drug product	2021-04-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	7342117*PED	2024-05-04		Pediatric extension		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	7982049*PED	2024-05-04		Pediatric extension		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	10058536	2036-03-31	U-3108	Drug product	2021-04-22	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N213801-001	10058536*PED	2036-10-01		Pediatric extension		`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 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	N213801-001	NP	2024-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213801-001	PED	2024-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	NP	2024-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213801-001	PED	2024-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	NP	2024-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213801-001	PED	2024-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	NP	2024-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213801-001	PED	2024-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213801-001	NP	2024-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213801-001	PED	2024-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	NP	2024-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213801-001	PED	2024-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	NP	2024-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213801-001	PED	2024-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	NP	2024-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213801-001	PED	2024-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213801-001	NP	2024-03-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213801-001	PED	2024-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	NP	2024-03-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213801-001	PED	2024-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213801-001	NP	2024-03-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213801-001	PED	2024-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213801-001	NP	2024-03-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213801-001	PED	2024-09-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213801-001	NP	2024-03-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N213801-001	PED	2024-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213801-001	NP	2024-03-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N213801-001	PED	2024-09-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	NP	2024-03-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213801-001	PED	2024-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213801-001	NP	2024-03-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213801-001	PED	2024-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213801-001	NP	2024-03-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213801-001	PED	2024-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	NP	2024-03-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213801-001	PED	2024-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	NP	2024-03-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213801-001	PED	2024-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	NP	2024-03-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213801-001	PED	2024-09-25	`a67488948f0b…`

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): 213801 application number: NDA213801 ndc (product): 0469-5020

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current
0469-5020	Myrbetriq	mirabegron	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69976	ORIG	2022-01-26
66919	ORIG	2021-03-30
66906	ORIG	2021-03-29