Application 076894
- Type
- ANDA
- Sponsor
- COREPHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 5MG | No | No |
| 002 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 10MG | No | No |
| 003 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 20MG | No | No |
| 004 | TORSEMIDE | TORSEMIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076894-001 | TORSEMIDE | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | |
| A076894-002 | TORSEMIDE | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | |
| A076894-003 | TORSEMIDE | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | |
| A076894-004 | TORSEMIDE | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076894-001 | AB |
| A076894-002 | AB |
| A076894-003 | AB |
| A076894-004 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-001 | TORSEMIDE | 5MG | TABLET / ORAL | AB | 2005-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-002 | TORSEMIDE | 10MG | TABLET / ORAL | AB | 2005-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-003 | TORSEMIDE | 20MG | TABLET / ORAL | AB | 2005-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-004 | TORSEMIDE | 100MG | TABLET / ORAL | AB | 2005-05-31 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076894-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076894-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076894-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A076894-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076894-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076894-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076894-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076894-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076894-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076894-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076894-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076894-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076894-004 | AB | 1 | d8e5a09893c0… |
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 | Chartwell RX, LLC | a3d68763-95e0-4ad6-89c2-c4b1c0b43948 | 2025-12-10 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 0b3cfce4-61fc-42ba-9ea7-51f81ea014f7 | 2025-10-22 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | e707eda7-4bde-4944-ae19-1b4fa35b6a3c | 2025-10-22 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | REMEDYREPACK INC. | 26a3af16-39fc-482d-8a8e-9473af4b0e3f | 2025-09-26 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | da8f2bf5-741c-45f6-b873-31a9fda2f880 | 2025-06-26 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 16dfba29-4c26-45e7-ac7d-b2ec2058e2bb | 2024-11-04 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Golden State Medical Supply, Inc. | 2411e6f8-4fc3-f986-e063-6294a90a055a | 2024-10-09 | Warnings, Adverse reactions | 076894 ANDA076894 |
| Torsemide | TORSEMIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 03fbbb85-4e0f-4f3b-b4b0-87f84cb33d47 | 2023-06-30 | Warnings, Adverse reactions | 076894 ANDA076894 |