Application 090613
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A090613-001 | TORSEMIDE | TORSEMIDE | 5MG | TABLET / ORAL | 2011-03-22 | ||
| A090613-002 | TORSEMIDE | TORSEMIDE | 10MG | TABLET / ORAL | 2011-03-22 | ||
| A090613-003 | TORSEMIDE | TORSEMIDE | 20MG | TABLET / ORAL | 2011-03-22 | ||
| A090613-004 | TORSEMIDE | TORSEMIDE | 100MG | TABLET / ORAL | 2011-03-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090613-001 | TORSEMIDE | 5MG | TABLET / ORAL | 2011-03-22 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A090613-002 | TORSEMIDE | 10MG | TABLET / ORAL | 2011-03-22 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A090613-003 | TORSEMIDE | 20MG | TABLET / ORAL | 2011-03-22 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A090613-004 | TORSEMIDE | 100MG | TABLET / ORAL | 2011-03-22 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 | TORSEMIDE | Major Pharmaceuticals | 09305350-e317-419c-96f5-aa8fbeb4044d | 2026-03-26 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | AvKARE | 7fc14338-92e4-cf57-a3e8-ef64d8d1026c | 2026-02-11 | Warnings, Adverse reactions | Torsemide 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 | TORSEMIDE | Chartwell RX, LLC | a3d68763-95e0-4ad6-89c2-c4b1c0b43948 | 2025-12-10 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Redpharm Drug | 44f2f06d-7bc4-5239-e063-6394a90aac5e | 2025-12-02 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 0b3cfce4-61fc-42ba-9ea7-51f81ea014f7 | 2025-10-22 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | e707eda7-4bde-4944-ae19-1b4fa35b6a3c | 2025-10-22 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | REMEDYREPACK INC. | 26a3af16-39fc-482d-8a8e-9473af4b0e3f | 2025-09-26 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | da8f2bf5-741c-45f6-b873-31a9fda2f880 | 2025-06-26 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| TORSEMIDE | TORSEMIDE | Direct_Rx | 91d45625-5ba6-b50f-e053-2a95a90ac314 | 2025-01-17 | Warnings, Adverse reactions | TORSEMIDE TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 16dfba29-4c26-45e7-ac7d-b2ec2058e2bb | 2024-11-04 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | e58a7d1c-6584-44c3-98ce-a3e9b64e9c82 | 2024-10-31 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | American Health Packaging | aaabbaca-ba6f-42d5-980d-71135c7c80ea | 2024-10-25 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Golden State Medical Supply, Inc. | 2411e6f8-4fc3-f986-e063-6294a90a055a | 2024-10-09 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | A-S Medication Solutions | 05c8a6ee-9517-453f-8dd6-7e5ca83c5a68 | 2024-10-01 | Warnings, Adverse reactions | Torsemide 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 | TORSEMIDE | XLCare Pharmaceuticals Inc. | 234ff9d7-a02e-417f-a1f9-94038783cc77 | 2024-09-10 | Warnings, Adverse reactions | Torsemide TORSEMIDE |
| Torsemide | TORSEMIDE | Bryant Ranch Prepack | 13d851b6-3355-4541-93e8-73cdaf0f13d1 | 2024-07-16 | Warnings, Adverse reactions | Torsemide TORSEMIDE |