Application 205484

Type: ANDA
Sponsor: JUBILANT GENERICS

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
A205484-001	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB		2024-10-02
A205484-002	SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB		2024-10-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205484-001	AB
A205484-002	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.

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	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205484-001	SOLIFENACIN SUCCINATE	5MG	TABLET / ORAL	AB	2024-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205484-002	SOLIFENACIN SUCCINATE	10MG	TABLET / ORAL	AB	2024-10-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205484-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205484-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205484-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205484-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205484-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205484-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205484-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205484-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205484-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205484-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205484-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205484-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205484-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205484-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205484-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205484-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205484-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205484-002	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205484-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205484-002	AB	1	`a50c72e98297…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Solifenacin succinate	SOLIFENACIN SUCCINATE	HEC Pharm USA Inc.	56026679-4002-a6c6-e063-6294a90a7b55	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Solifenacin succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCIATE	Bostal LLC	d155c739-6870-4938-ba91-8c1b4b90afe4	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Proficient Rx LP	1d8e8f6f-0a59-479f-8415-c5c5f19e1977	2026-02-01	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
solifenacin succinate	SOLIFENACIN SUCCINATE	Glenmark Pharmaceuticals Inc., USA	010c0657-c907-477f-8bd7-5d455a5f50eb	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: solifenacin succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCIATE	AvKARE	b0a0651e-1488-36b7-e053-2995a90a3f14	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
solifenacin succinate	SOLIFENACIN SUCCINATE	Ajanta Pharma USA Inc.	9558ed7a-e942-4261-8aea-6033352f79b8	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: solifenacin succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	f0b8f111-1d76-4b04-9e2f-9fca9e5a0b00	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	e04812c2-2ff7-4dff-9122-518c18f4935e	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	3788df43-42dd-4778-8289-e32b5844358e	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Apotex Corp.	1d96b386-febf-a510-a896-033e832c8f30	2025-10-11	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	dadb9462-953e-4319-b9f8-5b7255d1cf9c	2025-09-30	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	8d65dcb9-aa67-4cfb-9d15-43d0de327bd7	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2462e9a4-66a7-4340-9a81-617f3417b495	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	663d992d-23cc-4a8e-acd5-a4bea505ba3a	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	2dfc5d69-8f35-4f57-90b7-46a5f0f0febe	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Ascend Laboratories, LLC	97d8a21e-4618-460f-8cf5-97a9d946039e	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Golden State Medical Supply, Inc.	c84682ca-afca-a066-e053-2995a90a3257	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: SOLIFENACIN SUCCINATE generic name: SOLIFENACIN SUCCINATE
SOLIFENACIN SUCCINATE	SOLIFENACIN SUCCINATE	Bryant Ranch Prepack	7eb1a5d6-4972-44f4-8ab9-80b932bf81e0	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: SOLIFENACIN SUCCINATE generic name: SOLIFENACIN SUCCINATE
Solifenacin Succinate	SOLIFENACIN SUCCINATE	Aurobindo Pharma Limited	92b37f2d-b1cf-49e6-a13b-0ead92c0604c	2024-05-09	Warnings, Adverse reactions	Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE
solifenacin succinate	SOLIFENACIN SUCCINATE	Macleods Pharmaceuticals Limited	fbd6e753-1ed2-418a-8667-c674b215eabb	2024-03-06	Warnings, Adverse reactions	Name fallback brand name: solifenacin succinate generic name: SOLIFENACIN SUCCINATE