Home NDC 64380-941 solifenacin succinate
Product NDC 64380-941
11-digit product format 643800941
Labeler code 64380
Product ID 64380-941_7a72931b-b556-4893-b5a6-679a57c35af8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name solifenacin succinate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Strides Pharma Inc.
Application ANDA212214
Marketing category ANDA
Marketing start 2019-12-01
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 2020-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64380-941-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64380-941-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64380-941-05 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64380-941-04 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product U Excluded because listing certification expired 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64380-941-04 U Excluded because listing certification expired 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64380-941-05 U Excluded because listing certification expired 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A212214-001 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 A212214-002 SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26
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 2026-08-18 06:07:40 2026-07 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212214-001 SOLIFENACIN SUCCINATE 5MG TABLET / ORAL AB 2019-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212214-002 SOLIFENACIN SUCCINATE 10MG TABLET / ORAL AB 2019-09-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.