Application 017020
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANWARFIN | WARFARIN SODIUM | TABLET;ORAL | 2MG | No | No |
| 002 | PANWARFIN | WARFARIN SODIUM | TABLET;ORAL | 2.5MG | No | No |
| 003 | PANWARFIN | WARFARIN SODIUM | TABLET;ORAL | 5MG | No | No |
| 004 | PANWARFIN | WARFARIN SODIUM | TABLET;ORAL | 7.5MG | No | No |
| 005 | PANWARFIN | WARFARIN SODIUM | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017020-001 | PANWARFIN | WARFARIN SODIUM | 2MG | TABLET / ORAL | Approved before 1982 | ||
| N017020-002 | PANWARFIN | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | Approved before 1982 | ||
| N017020-003 | PANWARFIN | WARFARIN SODIUM | 5MG | TABLET / ORAL | Approved before 1982 | ||
| N017020-004 | PANWARFIN | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | Approved before 1982 | ||
| N017020-005 | PANWARFIN | WARFARIN SODIUM | 10MG | TABLET / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017020-001 | PANWARFIN | 2MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017020-002 | PANWARFIN | 2.5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017020-003 | PANWARFIN | 5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017020-004 | PANWARFIN | 7.5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017020-005 | PANWARFIN | 10MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Warfarin Sodium | WARFARIN SODIUM | Cardinal Health 107, LLC | 7c4deb97-9966-4c8e-9ba6-bb260b71e130 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | bd6ea120-5d1c-4815-94f2-81e28dc6b7a9 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 724b0061-f42a-4008-a078-09c800ee9785 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | f5fb1a5f-0dda-4f47-8683-ea63ac88a69d | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 1244c338-9140-425a-bf2a-9da6b4ac0287 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | d6083d68-4360-4d47-a1b2-1eb2763024bb | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 4dc2d94e-f856-47da-9d44-24773d97eb87 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | ba65ae56-ca3b-4895-9938-1dde2c3d34bf | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | A-S Medication Solutions | 8cd0e744-b499-4344-b1db-59f85950e169 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | A-S Medication Solutions | 991b1e3e-236e-44cf-ad61-7233f777ce67 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 6b227c9e-02e9-4ec9-8b11-3ab6fe5093e5 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 72d3ea20-27e4-4368-a666-a9b76530dbb9 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 61ab23a7-bc67-4777-854a-bf43c788a69a | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 7b3b6f89-1feb-4939-a95b-7ad0707f4d76 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 73b8e5ab-86f8-44f8-b290-346acb81c9ae | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 3f1c3083-91d1-488c-ad07-b198fda21da6 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | 748ebea5-c65b-4b5a-b237-f4eb880865fa | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | REMEDYREPACK INC. | b1bd0d02-eccb-4449-82b9-9b552835029e | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Northwind Health Company, LLC | f32d3578-0c90-567c-e053-2a95a90a23b8 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Northwind Health Company, LLC | f32dd451-3f7a-815b-e053-2995a90a528f | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.