Application 021518

Type: NDA
Sponsor: ASTELLAS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021518-001	VESICARE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL		RLD	2004-11-19
N021518-002	VESICARE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL		RLD	2004-11-19

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 · 86 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
2026-09-14 22:38:34	2026-08	N021518-001	VESICARE	5MG	TABLET / ORAL		RLD	2004-11-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021518-002	VESICARE	10MG	TABLET / ORAL		RLD	2004-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021518-001	VESICARE	5MG	TABLET / ORAL		RLD	2004-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021518-002	VESICARE	10MG	TABLET / ORAL		RLD	2004-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021518-001	VESICARE	5MG	TABLET / ORAL		RLD	2004-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021518-002	VESICARE	10MG	TABLET / ORAL		RLD	2004-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021518-001	VESICARE	5MG	TABLET / ORAL	AB	RLD	2004-11-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021518-002	VESICARE	10MG	TABLET / ORAL	AB	RLD, RS	2004-11-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021518-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021518-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021518-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021518-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021518-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021518-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021518-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021518-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021518-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021518-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021518-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021518-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021518-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021518-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021518-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021518-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021518-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021518-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021518-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021518-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021518-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021518-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021518-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021518-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021518-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021518-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021518-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021518-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021518-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021518-001	6017927*PED	2019-05-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021518-002	6017927*PED	2019-05-19	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021518-001	6017927*PED	2019-05-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021518-002	6017927*PED	2019-05-19	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021518-001	6017927*PED	2019-05-19	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021518-002	6017927*PED	2019-05-19	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021518-001	6017927*PED	2019-05-19	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021518-002	6017927*PED	2019-05-19	Pediatric extension	`ea99ee380514…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	b20003a6-f781-4563-9824-3e8b97c763c6	2024-01-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin succinate	SOLIFENACIN SUCCINATE	Actavis Pharma, Inc.	02e2aa54-1ed8-445a-a082-ac2c64b339fe	2023-11-28	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	8ab4f222-018f-40fc-a6aa-39dab563a8a0	2023-11-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	70fece2c-a59f-43f9-abbf-ac67500e90bb	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
solifenacin succinate	SOLIFENACIN SUCCINATE	Camber Pharmaceuticals, Inc.	6479d24f-373e-4c9e-abaf-349f90a2bbb1	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	c67107f4-348b-4a23-a67c-26fd8241ebd6	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Alembic Pharmaceuticals Inc.	48f82298-6600-4c69-a638-8dae15083fd9	2021-12-07	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Unichem Pharmaceuticals (USA), Inc.	51ff19b4-09ac-4796-8869-671ddd62c578	2021-10-22	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	d6525817-bea1-4a4c-bed4-4873ee202cc8	2021-05-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	ScieGen Pharmaceuticals, Inc.	a6f154d9-7463-4b80-b80e-c06a06e36141	2021-01-19	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Novadoz Pharmaceuticals LLC	98b99a4c-201d-46ee-b78c-7634a64d3a8d	2020-06-01	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Alembic Pharmaceuticals Limited	aea71cde-6d62-4f8d-b813-47064cb213d9	2019-05-22	Warnings, Adverse reactions	Name fallback generic name: SOLIFENACIN SUCCINATE

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0972	VESIcare	solifenacin succinate	A-S Medication Solutions	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-150	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
51248-151	VESIcare	solifenacin succinate	Astellas Pharma US, Inc.	NDA	Current
55154-3875	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
55154-3876	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
55154-3877	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
55154-3877	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
55154-3878	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
55154-3878	VESIcare	solifenacin succinate	Cardinal Health	NDA	Current
66993-397	Solifenacin Succinate	solifenacin succinate	Prasco	NDA AUTHORIZED GENERIC	Current
66993-398	Solifenacin Succinate	solifenacin succinate	Prasco	NDA AUTHORIZED GENERIC	Current
68151-5406	VESIcare	solifenacin succinate	Carilion Materials Management	NDA	Current
70518-1866	VESIcare	solifenacin succinate	REMEDYREPACK INC.	NDA	Current
70518-1866	VESIcare	solifenacin succinate	REMEDYREPACK INC.	NDA	Current
70518-1866	VESIcare	solifenacin succinate	REMEDYREPACK INC.	NDA	Current
70518-2094	VESIcare	solifenacin succinate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63325	SUPPL	2020-05-28
63304	SUPPL	2020-05-27
58516	SUPPL	2019-05-02
58502	SUPPL	2019-05-01
52346	ORIG	2017-07-20
52345	ORIG	2017-07-20
52344	ORIG	2017-07-20
52343	ORIG	2017-07-20
51594	ORIG	2017-07-20
51593	ORIG	2017-07-20
51592	ORIG	2017-07-20
37132	SUPPL	2013-10-17
5609	SUPPL	2013-10-11
37131	SUPPL	2013-04-01
5608	SUPPL	2013-04-01
37130	SUPPL	2012-08-06
5607	SUPPL	2012-08-06
37129	SUPPL	2012-07-25
5606	SUPPL	2012-07-17
28009	SUPPL	2012-06-12
37127	SUPPL	2012-06-11
37128	SUPPL	2012-01-23
28010	SUPPL	2012-01-19
5605	SUPPL	2011-03-14
37126	SUPPL	2011-03-11
5604	SUPPL	2010-07-14
15663	SUPPL	2010-07-01
5603	SUPPL	2008-11-21
37125	SUPPL	2008-11-19
28008	SUPPL	2008-10-30
28007	SUPPL	2008-02-14
15662	SUPPL	2008-02-14
5602	SUPPL	2007-07-24
15661	SUPPL	2007-07-16
42199	ORIG	2005-02-08
15660	ORIG	2004-12-03
28006	ORIG	2004-12-02
68846	SUPPL	1900-01-01
68845	SUPPL	1900-01-01