Home NDC 48792-7909-2 solifenacin succinate
Product NDC 48792-7909
Requested package NDC 48792-7909-2
11-digit product format 487927909
Labeler code 48792
Product ID 48792-7909_a3b8c82b-8380-463e-e053-2995a90ae3b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name solifenacin succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sunshine Lake Pharma Co., Ltd.
Application ANDA213346
Marketing category ANDA
Marketing start 2020-04-25
Marketing end 0000-00-00
Substance SOLIFENACIN SUCCINATE
Active strength 5 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A213346-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2020-04-13 A213346-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2020-04-13
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 · 74 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 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213346-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL 2020-04-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213346-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL 2020-04-13 87673890dc5c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2020-11-12 02:37 UTC 2020-11 A213346-001 AB 1 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A213346-002 AB 1 c0c555d07b60…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213346-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213346-002 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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 48792-7909-2 48792790902 90 TABLET, FILM COATED in 1 BOTTLE (48792-7909-2) 2020-04-25 0000-00-00 No No Current