Application 021595
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SANCTURA | TROSPIUM CHLORIDE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021595-001 | SANCTURA | TROSPIUM CHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 |
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.
| 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| 2026-08 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021595-001 | SANCTURA | 20MG | TABLET / ORAL | RLD | 2004-05-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021595-001 | SANCTURA | 20MG | TABLET / ORAL | RLD | 2004-05-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2004-05-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021595-001 | SANCTURA | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2004-05-28 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Trospium Chloride | TROSPIUM CHLORIDE | MAJOR PHARMACEUTICALS | 7a2fea88-266d-4fc0-a476-66dc6effcff7 | 2026-09-03 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Slate Run Pharmaceuticals, LLC | c1c8bd8b-7ff8-5940-e053-2995a90ae656 | 2026-08-05 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | REMEDYREPACK INC. | 48d1b484-ee0a-4d66-9b45-4ba34e65ed13 | 2026-04-23 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Bryant Ranch Prepack | 095f54ba-4d43-4266-8942-eede6678ee3b | 2026-04-14 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Glenmark Pharmaceuticals Inc., USA | d5c837a4-d1c6-4615-b7ad-27f3162a03aa | 2025-12-30 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Chartwell RX, LLC | 801f2143-6816-4f34-b65d-16bb2cf07975 | 2025-12-11 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Golden State Medical Supply, Inc. | 8e5e2b3a-467b-4312-9778-8ff2ce938838 | 2025-12-11 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride ER | TROSPIUM CHLORIDE | Bryant Ranch Prepack | c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1 | 2025-10-21 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Bryant Ranch Prepack | 832d1e92-1024-495a-bb7f-590412aae699 | 2025-10-21 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6303cf3c-175c-46ff-9b88-05f6ea7a2135 | 2025-10-09 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Actavis Pharma, Inc. | 8b8d434c-daa2-4bf2-bde6-3e59f81bd88b | 2025-07-31 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Major Pharmaceuticals | 35ae4d64-4625-4fdd-a2d4-e20b87c56876 | 2025-07-21 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Zameer Pharmaceuticals LLC | 048b4bc7-c77e-40fc-9bfb-bb35c6a3f871 | 2024-12-19 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Macleods Pharmaceuticals Limited | fcb13b21-e4a2-461b-b3cb-0daedc722050 | 2024-09-03 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride ER | TROSPIUM CHLORIDE | Bryant Ranch Prepack | dfc1af0b-b0e7-43fd-8da0-65281963bc3e | 2024-07-16 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride | TROSPIUM CHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1523cb4c-3a52-6c18-e063-6394a90a396f | 2024-04-02 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Bryant Ranch Prepack | 871d70aa-4a7d-44dd-933c-969164b75942 | 2023-11-07 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| Trospium Chloride ER | TROSPIUM CHLORIDE | Bryant Ranch Prepack | 2f431dd1-e130-45e5-a796-1662f498585e | 2023-11-06 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Bryant Ranch Prepack | 1065cfd9-3d32-466c-8dff-c81eae1a0533 | 2023-10-23 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
| TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | Granules Pharmaceuticals Inc. | 5c088397-f407-4606-95a0-d9fe619888c3 | 2023-07-28 | Warnings, Adverse reactions | TROSPIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 28220 | SUPPL | 2012-07-25 |
| 5818 | SUPPL | 2012-07-25 |
| 37312 | SUPPL | 2012-07-24 |
| 15850 | SUPPL | 2012-07-24 |
| 37310 | SUPPL | 2011-09-30 |
| 28218 | SUPPL | 2011-09-28 |
| 37311 | SUPPL | 2011-02-09 |
| 28219 | SUPPL | 2011-02-04 |
| 15849 | SUPPL | 2009-06-04 |
| 28217 | SUPPL | 2006-12-28 |
| 28216 | SUPPL | 2006-09-15 |
| 37309 | SUPPL | 2006-09-12 |
| 28215 | SUPPL | 2005-03-14 |
| 15848 | SUPPL | 2005-03-14 |
| 42226 | ORIG | 2004-07-08 |
| 15847 | ORIG | 2004-06-01 |
| 5817 | ORIG | 2004-06-01 |