Application 210281

Type: ANDA
Sponsor: JIANGXI BOYA SEEHOT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	TABLET;ORAL	5MG	No	No
002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	TABLET;ORAL	10MG	No	No

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
A210281-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A210281-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210281-001	AB
A210281-002	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210281-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210281-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A210281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210281-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210281-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210281-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210281-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210281-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210281-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210281-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210281-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210281-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210281-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210281-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210281-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210281-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210281-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210281-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210281-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210281-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210281-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210281-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210281-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210281-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210281-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210281-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210281-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210281-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210281-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210281-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin Succinate	SOLIFENACIN SUCCIATE	Bostal LLC	d155c739-6870-4938-ba91-8c1b4b90afe4	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210281 application number: ANDA210281 ndc (product): 35561-286 ndc (product): 35561-285
Solifenacin Succinate	SOLIFENACIN SUCCIATE	AvKARE	b0a0651e-1488-36b7-e053-2995a90a3f14	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210281 application number: ANDA210281 ndc (product): 42291-740 ndc (product): 42291-739

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35561-285	Solifenacin Succinate	solifenacin succiate	AustarPharma LLC	ANDA	Current
35561-285	Solifenacin Succinate	solifenacin succiate	AustarPharma LLC	ANDA	Current
35561-285	Solifenacin Succinate	solifenacin succiate	AustarPharma LLC	ANDA	Current
35561-286	Solifenacin Succinate	solifenacin succinate	AustarPharma LLC	ANDA	Current
35561-286	Solifenacin Succinate	solifenacin succinate	AustarPharma LLC	ANDA	Current
35561-286	Solifenacin Succinate	solifenacin succinate	AustarPharma LLC	ANDA	Current
42291-739	Solifenacin Succinate	solifenacin succiate	AvKARE	ANDA	Current
42291-739	Solifenacin Succinate	solifenacin succiate	AvKARE	ANDA	Current
42291-740	Solifenacin Succinate	solifenacin succinate	AvKARE	ANDA	Current
42291-740	Solifenacin Succinate	solifenacin succinate	AvKARE	ANDA	Current
51407-227	Solifenacin Succinate	solifenacin succiate	Golden State Medical Supply Inc.	ANDA	Current
51407-227	Solifenacin Succinate	solifenacin succiate	Golden State Medical Supply	ANDA	Current
51407-227	Solifenacin Succinate	solifenacin succiate	Golden State Medical Supply	ANDA	Current
51407-227	Solifenacin Succinate	solifenacin succiate	Golden State Medical Supply, Inc.	ANDA	Current
51407-228	Solifenacin Succinate	solifenacin succinate	Golden State Medical Supply Inc.	ANDA	Current
51407-228	Solifenacin Succinate	solifenacin succinate	Golden State Medical Supply	ANDA	Current
51407-228	Solifenacin Succinate	solifenacin succinate	Golden State Medical Supply	ANDA	Current
51407-228	Solifenacin Succinate	solifenacin succinate	Golden State Medical Supply, Inc.	ANDA	Current
69367-295	Solifenacin Succinate	solifenacin succiate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-296	Solifenacin Succinate	solifenacin succinate	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-580	Solifenacin Succinate	solifenacin succiate	Proficient Rx LP	ANDA	Current
71205-580	Solifenacin Succinate	solifenacin succiate	Proficient Rx LP	ANDA	Current
71205-933	Solifenacin Succinate	solifenacin succiate	Proficient Rx LP	ANDA	Current
71205-933	Solifenacin Succinate	solifenacin succiate	Proficient Rx LP	ANDA	Current
71205-934	Solifenacin Succinate	solifenacin succinate	Proficient Rx LP	ANDA	Current
71205-934	Solifenacin Succinate	solifenacin succinate	Proficient Rx LP	ANDA	Current