Application 020136
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEMADEX | TORSEMIDE | TABLET;ORAL | 5MG | Yes | No |
| 002 | DEMADEX | TORSEMIDE | TABLET;ORAL | 10MG | Yes | No |
| 003 | DEMADEX | TORSEMIDE | TABLET;ORAL | 20MG | Yes | Yes |
| 004 | DEMADEX | TORSEMIDE | TABLET;ORAL | 100MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020136-001 | DEMADEX | TORSEMIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | |
| N020136-002 | DEMADEX | TORSEMIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | |
| N020136-003 | DEMADEX | TORSEMIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | |
| N020136-004 | DEMADEX | TORSEMIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020136-001 | DEMADEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020136-002 | DEMADEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020136-003 | DEMADEX | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020136-004 | DEMADEX | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1993-08-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020136-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020136-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020136-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020136-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N020136-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020136-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020136-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020136-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020136-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020136-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020136-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020136-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020136-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020136-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020136-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020136-004 | AB | 1 | ea99ee380514… |
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 | REMEDYREPACK INC. | 1c755d94-b846-4336-a968-aa1b92dc0ac0 | 2026-07-21 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Major Pharmaceuticals | 09305350-e317-419c-96f5-aa8fbeb4044d | 2026-03-26 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | AvKARE | 7fc14338-92e4-cf57-a3e8-ef64d8d1026c | 2026-02-11 | Warnings, Adverse reactions | TORSEMIDE |
| SOAANZ | TORSEMIDE | Sarfez Pharmaceuticals Inc | 05eaa163-b6e9-438a-85f8-6a60e743d460 | 2026-01-09 | TORSEMIDE | |
| Torsemide | TORSEMIDE | AvPAK | f1439b9c-c01c-a6d4-594b-d92b8e0af26e | 2025-12-31 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Chartwell RX, LLC | a3d68763-95e0-4ad6-89c2-c4b1c0b43948 | 2025-12-10 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Redpharm Drug | 44f2f06d-7bc4-5239-e063-6394a90aac5e | 2025-12-02 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 0b3cfce4-61fc-42ba-9ea7-51f81ea014f7 | 2025-10-22 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | e707eda7-4bde-4944-ae19-1b4fa35b6a3c | 2025-10-22 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | REMEDYREPACK INC. | 26a3af16-39fc-482d-8a8e-9473af4b0e3f | 2025-09-26 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | da8f2bf5-741c-45f6-b873-31a9fda2f880 | 2025-06-26 | Warnings, Adverse reactions | TORSEMIDE |
| TORSEMIDE | TORSEMIDE | Direct_Rx | 91d45625-5ba6-b50f-e053-2a95a90ac314 | 2025-01-17 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 16dfba29-4c26-45e7-ac7d-b2ec2058e2bb | 2024-11-04 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | e58a7d1c-6584-44c3-98ce-a3e9b64e9c82 | 2024-10-31 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | American Health Packaging | aaabbaca-ba6f-42d5-980d-71135c7c80ea | 2024-10-25 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Golden State Medical Supply, Inc. | 2411e6f8-4fc3-f986-e063-6294a90a055a | 2024-10-09 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | 05c8a6ee-9517-453f-8dd6-7e5ca83c5a68 | 2024-10-01 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 99b537f3-1fbf-48b7-ac3e-0a43e6aab313 | 2024-09-30 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | XLCare Pharmaceuticals Inc. | 234ff9d7-a02e-417f-a1f9-94038783cc77 | 2024-09-10 | Warnings, Adverse reactions | TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 13d851b6-3355-4541-93e8-73cdaf0f13d1 | 2024-07-16 | Warnings, Adverse reactions | TORSEMIDE |