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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage48792-790948792-7909-2DDiscontinued by firm2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213346-001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE5MGTABLET / ORALAB2020-04-13
A213346-002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATE10MGTABLET / ORALAB2020-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213346-001AB
A213346-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-134b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213346-001SOLIFENACIN SUCCINATE5MGTABLET / ORAL2020-04-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213346-002SOLIFENACIN SUCCINATE10MGTABLET / ORAL2020-04-1387673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A213346-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A213346-002AB1c0c555d07b60…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213346-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213346-002AB1a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solifenacin succinateSOLIFENACIN SUCCINATEHEC Pharm USA Inc.56026679-4002-a6c6-e063-6294a90a7b552026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213346
application number: ANDA213346

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
48792-7909-24879279090290 TABLET, FILM COATED in 1 BOTTLE (48792-7909-2) 2020-04-250000-00-00NoNoCurrent