Home Applications 211423 Application 211423
Type ANDA
Sponsor CSPC OUYI 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 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 A211423-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 A211423-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 80 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 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 brand name: Solifenacin succinate generic name: SOLIFENACIN SUCCINATE Solifenacin succinate SOLIFENACIN SUCCINATE Actavis Pharma, Inc. 02e2aa54-1ed8-445a-a082-ac2c64b339fe 2023-11-28 Warnings, Adverse reactions Name fallback brand name: Solifenacin succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Proficient Rx LP 8ab4f222-018f-40fc-a6aa-39dab563a8a0 2023-11-01 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Proficient Rx LP 70fece2c-a59f-43f9-abbf-ac67500e90bb 2022-09-01 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate 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 brand name: solifenacin succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Proficient Rx LP c67107f4-348b-4a23-a67c-26fd8241ebd6 2022-06-01 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Alembic Pharmaceuticals Inc. 48f82298-6600-4c69-a638-8dae15083fd9 2021-12-07 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate 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 brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Proficient Rx LP d6525817-bea1-4a4c-bed4-4873ee202cc8 2021-05-01 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE ScieGen Pharmaceuticals, Inc. a6f154d9-7463-4b80-b80e-c06a06e36141 2021-01-19 Warnings, Adverse reactions Name fallback brand name: SOLIFENACIN SUCCINATE generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Novadoz Pharmaceuticals LLC 98b99a4c-201d-46ee-b78c-7634a64d3a8d 2020-06-01 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate generic name: SOLIFENACIN SUCCINATE Solifenacin Succinate SOLIFENACIN SUCCINATE Alembic Pharmaceuticals Limited aea71cde-6d62-4f8d-b813-47064cb213d9 2019-05-22 Warnings, Adverse reactions Name fallback brand name: Solifenacin Succinate 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69844-047 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current 69844-047 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current 69844-047 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current 69844-048 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current 69844-048 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current 69844-048 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE Graviti Pharmaceuticals Private Limited ANDA Current