Application 040145
- Type
- ANDA
- Sponsor
- BARR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 1MG | No | No |
| 002 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 2MG | No | No |
| 003 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 2.5MG | No | No |
| 004 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 4MG | No | No |
| 005 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 5MG | No | No |
| 006 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 7.5MG | No | No |
| 007 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 10MG | No | No |
| 008 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 3MG | No | No |
| 009 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 6MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040145-001 | WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-002 | WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-003 | WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-004 | WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-005 | WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-006 | WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-007 | WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET / ORAL | 1997-03-26 | ||
| A040145-008 | WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET / ORAL | 1998-11-05 | ||
| A040145-009 | WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET / ORAL | 1998-11-05 |
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 | A040145-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-004 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-005 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-006 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-007 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 1997-03-26 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-008 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 1998-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040145-009 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 1998-11-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-004 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-005 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-006 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-007 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 1997-03-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-008 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 1998-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040145-009 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 1998-11-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-004 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-005 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-006 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-007 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 1997-03-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-008 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 1998-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040145-009 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 1998-11-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-004 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-005 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-006 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-007 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 1997-03-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-008 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 1998-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040145-009 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 1998-11-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040145-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 1997-03-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040145-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1997-03-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040145-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 1997-03-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040145-004 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 1997-03-26 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-007 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-008 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040145-009 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-004 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-005 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-006 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-007 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-008 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040145-009 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-006 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-007 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-008 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040145-009 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-006 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-007 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-008 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040145-009 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040145-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040145-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040145-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040145-004 | AB | 1 | 4b0b4de00fa7… |
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 | A-S Medication Solutions | 991b1e3e-236e-44cf-ad61-7233f777ce67 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Amneal Pharmaceuticals LLC | 558b7a0d-5490-4c1b-802e-3ab3f1efe760 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Coupler LLC | 52bacf1e-9ba8-7eca-e063-6394a90ab60b | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Coupler LLC | 5256c518-31bf-f73b-e063-6394a90a71da | 2026-05-21 | 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 | WARFARIN SODIUM | REMEDYREPACK INC. | 72d3ea20-27e4-4368-a666-a9b76530dbb9 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium 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 | WARFARIN SODIUM | REMEDYREPACK INC. | 7b3b6f89-1feb-4939-a95b-7ad0707f4d76 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium 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 | WARFARIN SODIUM | REMEDYREPACK INC. | 3f1c3083-91d1-488c-ad07-b198fda21da6 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium 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 | WARFARIN SODIUM | REMEDYREPACK INC. | b1bd0d02-eccb-4449-82b9-9b552835029e | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Aphena Pharma Solutions - Tennessee, LLC | 4f276251-49b7-438f-9c47-f1cdfc47e519 | 2026-01-22 | 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 | WARFARIN SODIUM | Northwind Health Company, LLC | f32dd451-3f7a-815b-e053-2995a90a528f | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Northwind Health Company, LLC | f86fe457-a1b6-e54d-e053-6294a90a9bc7 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Cardinal Health 107, LLC | cdbbc317-35d3-42ba-94f0-c83891358529 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 3aeb6bb1-bc43-4fe7-83f2-36cd0bf46102 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 8eae6b6c-1851-4342-b320-7e1896894658 | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | a1860448-d4ef-40f2-b096-056429ca3aea | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0555-0834 | Warfarin Sodium | Warfarin Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0555-0834 | Warfarin Sodium | Warfarin Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50090-1756 | Warfarin Sodium | Warfarin Sodium | A-S Medication Solutions | ANDA | Current |
| 51655-278 | WARFARIN SODIUM | WARFARIN SODIUM | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 63629-4748 | Warfarin Sodium | Warfarin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-6400 | Warfarin Sodium | Warfarin Sodium | Bryant Ranch Prepack | ANDA | Current |
| 64725-0833 | Warfarin Sodium | Warfarin Sodium | TYA Pharmaceuticals | ANDA | Current |