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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-005 | WARFARIN SODIUM | 4MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-006 | WARFARIN SODIUM | 5MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-007 | WARFARIN SODIUM | 6MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-008 | WARFARIN SODIUM | 7.5MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200104-009 | WARFARIN SODIUM | 10MG | TABLET / ORAL | 2013-06-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200104-001 | WARFARIN SODIUM | 1MG | TABLET / ORAL | 2013-06-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200104-002 | WARFARIN SODIUM | 2MG | TABLET / ORAL | 2013-06-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200104-003 | WARFARIN SODIUM | 2.5MG | TABLET / ORAL | 2013-06-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200104-004 | WARFARIN SODIUM | 3MG | TABLET / ORAL | 2013-06-27 | b8a1b40f171c… |
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 | A-S Medication Solutions | 541c9a70-adaf-4ef3-94ba-ad4e70dfa057 | 2026-07-23 | 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 | WARFARIN | REMEDYREPACK INC. | d7fb4290-ed37-4ed3-ae51-c400191961dc | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 51e98fb6-ba76-497e-95d8-fe895ef0b7ed | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | a4cf3107-5646-4b91-8aae-94548e4409ef | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 2fb8b8d5-f643-4069-8e47-5eae31a8fbc8 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 884cdbf6-0a52-4126-8e14-b0d7c9367e33 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 8eddba53-19c4-411b-b0d4-cb2f948ba125 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 2cbcc99d-9107-4d39-a1e9-e19305de8b5d | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 8ee94789-72d2-4c42-9dbd-0501e9767d97 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium |
| Warfarin Sodium | WARFARIN | REMEDYREPACK INC. | 545ec40d-2db1-4581-b3ec-ce195e5f5400 | 2026-06-25 | 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 | WARFARIN SODIUM | REMEDYREPACK INC. | 1244c338-9140-425a-bf2a-9da6b4ac0287 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium 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 | WARFARIN SODIUM | REMEDYREPACK INC. | 4dc2d94e-f856-47da-9d44-24773d97eb87 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Warfarin Sodium 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 | 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 | 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 |