Application 210224

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A210224-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2019-05-20
A210224-002	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
A210224-001	AB
A210224-002	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	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210224-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2019-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210224-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2019-05-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210224-002	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	A210224-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210224-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210224-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210224-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210224-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210224-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210224-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210224-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210224-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210224-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210224-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210224-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210224-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210224-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210224-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210224-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210224-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210224-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210224-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210224-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210224-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210224-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210224-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210224-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210224-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210224-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210224-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210224-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210224-002	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	f0b8f111-1d76-4b04-9e2f-9fca9e5a0b00	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	e04812c2-2ff7-4dff-9122-518c18f4935e	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	3788df43-42dd-4778-8289-e32b5844358e	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	dadb9462-953e-4319-b9f8-5b7255d1cf9c	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 71335-1729
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	8d65dcb9-aa67-4cfb-9d15-43d0de327bd7	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 63629-8868
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2462e9a4-66a7-4340-9a81-617f3417b495	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 63629-8870
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	663d992d-23cc-4a8e-acd5-a4bea505ba3a	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 63629-8869
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2dfc5d69-8f35-4f57-90b7-46a5f0f0febe	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 63629-8867
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Ascend Laboratories, LLC	97d8a21e-4618-460f-8cf5-97a9d946039e	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 67877-528 ndc (product): 67877-527
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	c67107f4-348b-4a23-a67c-26fd8241ebd6	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210224 application number: ANDA210224 ndc (product): 71205-561

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-8867	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8867	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8868	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8868	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8869	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8869	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8870	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
63629-8870	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
67877-527	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
67877-527	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
67877-527	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
67877-528	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
67877-528	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
67877-528	Solifenacin Succinate	Solifenacin Succinate	Ascend Laboratories, LLC	ANDA	Current
71205-561	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71205-561	Solifenacin Succinate	Solifenacin Succinate	Proficient Rx LP	ANDA	Current
71335-1729	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current
71335-1729	Solifenacin Succinate	Solifenacin Succinate	Bryant Ranch Prepack	ANDA	Current