Application 020137
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEMADEX | TORSEMIDE | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | DEMADEX | TORSEMIDE | INJECTABLE;INJECTION | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020137-001 | DEMADEX | TORSEMIDE | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | |
| N020137-002 | DEMADEX | TORSEMIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 |
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 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 1993-08-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-08-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1993-08-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | RLD | 1993-08-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | RLD | 1993-08-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) | INJECTABLE / INJECTION | RLD | 1993-08-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) | INJECTABLE / INJECTION | RLD | 1993-08-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020137-001 | DEMADEX | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1993-08-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020137-002 | DEMADEX | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1993-08-23 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Torsemide | TORSEMIDE | Aurobindo Pharma Limited | 55e88727-864e-4313-860c-31a6ca45168f | 2024-05-08 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Rising Pharma Holdings, Inc. | 3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd | 2024-05-08 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | 159e8c90-ebc6-0991-e063-6394a90aae19 | 2024-04-08 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Golden State Medical Supply, Inc. | a6055317-8826-df85-e053-2a95a90a5378 | 2023-12-28 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Hikma Pharmaceuticals USA Inc. | fde1d1be-0faa-440a-9039-bdb103288c76 | 2023-08-31 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47 | 2023-06-30 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | 3e9c6ee1-c49f-4f59-9391-8a9b57becb02 | 2023-05-25 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | 3ed913ba-f0c0-4ba5-9440-73c4374f4226 | 2023-05-25 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | f24151c8-02cd-4b07-a7fd-796903210aba | 2023-05-23 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 201e892d-d963-4c6a-b35b-c5780b01f659 | 2022-12-15 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Aphena Pharma Solutions - Tennessee, LLC | b869bc45-1ebb-42fb-82c5-603f09835790 | 2017-10-19 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Camber Pharmaceuticals, Inc. | 0d4a4ef9-0944-452c-b014-bd822bfb9dd9 | 2017-08-14 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Teva Pharmaceuticals USA, Inc. | 8a95cbdb-0601-47a5-9b3a-0c3b0629ceb9 | 2017-02-28 | Warnings, Adverse reactions | TORSEMIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.