Application 211657

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

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
A211657-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A211657-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	RS	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
A211657-001	AB
A211657-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	RS	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211657-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211657-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211657-002	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	A211657-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211657-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211657-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211657-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211657-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211657-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211657-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211657-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211657-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211657-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211657-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211657-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211657-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211657-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211657-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211657-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211657-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211657-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211657-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211657-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211657-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211657-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211657-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211657-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211657-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211657-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211657-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211657-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211657-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	c84682ca-afca-a066-e053-2995a90a3257	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657 ndc (product): 51407-471 ndc (product): 51407-472
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	7eb1a5d6-4972-44f4-8ab9-80b932bf81e0	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	49346a96-3d96-4702-b96e-94e635510dba	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657 ndc (product): 63629-8532
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	a6f154d9-7463-4b80-b80e-c06a06e36141	2021-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211657 application number: ANDA211657 ndc (product): 50228-427 ndc (product): 50228-428

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-427	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-427	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-427	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-427	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-428	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-428	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-428	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-428	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	ANDA	Current
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply Inc.	ANDA	Current
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply	ANDA	Current
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-254	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply Inc.	ANDA	Current
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply	ANDA	Current
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-255	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-471	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
51407-472	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	ANDA	Current
63629-8532	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	ANDA	Current
63629-8532	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	ANDA	Current
69367-239	Solifenacin Succinate	Solifenacin Succinate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-239	Solifenacin Succinate	Solifenacin Succinate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-240	Solifenacin Succinate	Solifenacin Succinate	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-240	Solifenacin Succinate	Solifenacin Succinate	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-539	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-540	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-986	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-986	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-987	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-987	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current