Application 200104
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
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 | 3MG | No | No |
| 005 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 4MG | No | No |
| 006 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 5MG | No | No |
| 007 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 6MG | No | No |
| 008 | WARFARIN SODIUM | WARFARIN SODIUM | TABLET;ORAL | 7.5MG | No | No |
| 009 | WARFARIN SODIUM | 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 |
|---|---|---|---|---|---|---|---|
| A200104-001 | WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-002 | WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-003 | WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-004 | WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-005 | WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-006 | WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-007 | WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-008 | WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | ||
| A200104-009 | WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 |
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 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-005 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-006 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-007 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-008 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200104-009 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-006 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-007 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-008 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200104-009 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-005 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-006 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-007 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-008 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200104-009 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-005 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-006 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-007 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-008 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A200104-009 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200104-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200104-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200104-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200104-004 | AB | 1 | 79d66fd596c7… |
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 | Bryant Ranch Prepack | d166f83b-7052-4dc7-b7d4-47faae7dcaed | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | e7f78a33-71eb-4aac-ba9d-70f75136fab0 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 694e258d-86bd-440c-870b-a7d27fb1c467 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Golden State Medical Supply, Inc. | a2f6c9f7-87dc-7428-e053-2995a90a1de6 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 21255cd5-3c2e-4574-9620-9347d14256b3 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 4f8afe14-897c-458b-b76f-9bae6fa6110e | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 44077bb7-6007-4c15-bbcd-a7a02ac081ce | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Bryant Ranch Prepack | 7f604dc4-c2cd-4b1f-b94d-b5877a1be66b | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Golden State Medical Supply, Inc. | ba8b4ead-d080-91e7-e053-2995a90a82fe | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Jantoven | WARFARIN SODIUM | Upsher-Smith Laboratories, LLC | 19a69a72-ac5d-45d5-a94d-a5aaecbe4730 | 2025-07-08 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Teva Pharmaceuticals USA, Inc. | 0cbce382-9c88-4f58-ae0f-532a841e8f95 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | Sun Pharmaceutical Industries, Inc. | 8ad881e0-ca41-42ad-9d7d-eb85b3a30af0 | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Coupler LLC | 2f2119e8-f583-ba16-e063-6394a90a13a2 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Coupler LLC | 2d58d204-4976-95cf-e063-6394a90a34b7 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | Bryant Ranch Prepack | 8c876dd3-d659-479e-994c-39454c7028cc | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| WARFARIN SODIUM | WARFARIN SODIUM | Direct_Rx | efded00a-22b9-1da7-e053-2995a90a58ca | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM WARFARIN SODIUM |
| WARFARIN SODIUM | WARFARIN SODIUM | DIRECT RX | c186d1ff-64dd-bfcb-e053-2a95a90af800 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | WARFARIN SODIUM WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN | Preferred Pharmaceuticals Inc. | ac117f50-8e67-4203-8d97-e53dd0687c20 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN SODIUM | A-S Medication Solutions | 53a6947e-ef3f-403b-9ccc-1740ae5efad0 | 2024-12-24 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium WARFARIN SODIUM |
| Warfarin Sodium | WARFARIN SODIUM | American Health Packaging | ab047628-67d0-4a64-8d77-36b054969b44 | 2024-10-04 | 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.