Application 086123
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 2MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086123-001 | WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A086123-001 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 1982-08-17 | 3a93d1ddd44b… |
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 | 5a7d347b-391e-4e9b-a691-1962c7da4fc7 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Bryant Ranch Prepack | 7fdfd870-e72d-4d88-b6d9-1d711b66d09f | 2024-01-02 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Bryant Ranch Prepack | 3dd9f8ce-75e0-426a-9d22-6af7742a0ca7 | 2023-12-14 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Bryant Ranch Prepack | addaac3d-6fb5-484f-8535-04eb410d2bf0 | 2023-10-20 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN SODIUM | A-S Medication Solutions | 35bf53df-994b-4c32-8bdb-9227e8e195c6 | 2023-08-30 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Bryant Ranch Prepack | c41b7c23-8053-428a-ac1d-8395e714c2f1 | 2023-04-12 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN SODIUM | Proficient Rx LP | 388bfa49-f4f7-412a-80ff-d09442489e2b | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | e73d37f8-8a28-4d93-9529-fd1e2c84228a | 2021-08-17 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 2c8f47c6-a180-4ad8-b962-04069d2270cb | 2021-07-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Aphena Pharma Solutions - Tennessee, LLC | 52b3c2f6-b5ca-44ae-bdcc-552d5191034f | 2021-01-28 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Aphena Pharma Solutions - Tennessee, LLC | a98916a5-cdb2-4251-bdea-0245c763b2f1 | 2020-12-15 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Exelan Pharmaceuticals Inc. | c0cc4511-e656-4b6d-96cd-e02e76173b9d | 2020-09-09 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Aphena Pharma Solutions - Tennessee, LLC | 91f24482-d4cb-4a09-a97e-64f6e49071ee | 2020-08-03 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN SODIUM | Proficient Rx LP | 73048ed9-242f-4f86-a8db-9c7547daa01d | 2020-05-01 | 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.