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 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 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 · 76 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 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…2021-12-28 21:50 UTC 2021-12 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211423-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-12-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211423-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-12-11 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 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
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