Application 209426
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 125MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 250MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209426-001 | DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | ||
| A209426-002 | DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | ||
| A209426-003 | DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | AB | 2024-11-05 | d8e5a09893c0… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209426-001 | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209426-002 | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209426-003 | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION / ORAL | 2024-11-05 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209426-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209426-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209426-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209426-003 | AB | 1 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209426-003 | AB | 1 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Exjade | DEFERASIROX | Novartis Pharmaceuticals Corporation | 3495a70c-870c-4968-940e-8baea152cf85 | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX |
| Deferasirox | DEFERASIROX | AvKARE | 485c4834-7bec-2018-e063-6294a90ab4e3 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Novadoz Pharmaceuticals LLC | a03c7657-fdca-4acb-ad82-c24680e90eae | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Jadenu | DEFERASIROX | Novartis Pharmaceuticals Corporation | fee89140-fff1-4443-9f42-24ac004fcda1 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX |
| Deferasirox | DEFERASIROX | Actavis Pharma, Inc. | ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| DEFERASIROX | DEFERASIROX | Aurobindo Pharma Limited | c220484e-1e6a-4a0c-a221-60223f3bc24c | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX DEFERASIROX |
| Deferasirox | DEFERASIROX | Ascend Laboratories, LLC | da3295fc-5210-46a3-a5cc-7b9ec9265eca | 2025-07-11 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Ascend Laboratories, LLC | 0fb210b3-6a3d-4313-83ce-52012e384f9b | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Bionpharma Inc. | dc690f20-533e-490e-b13d-143382e02351 | 2025-03-05 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Camber Pharmaceuticals, Inc. | 65453013-c360-4835-8358-2a278a4a32db | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox Oral Granules | DEFERASIROX | EPIC PHARMA, LLC | 7eda83c3-a282-47f6-9f06-d2f9612f5c5b | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX |
| deferasirox | DEFERASIROX | Zydus Lifesciences Limited | fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98 | 2024-11-26 | deferasirox DEFERASIROX | |
| deferasirox | DEFERASIROX | Glenmark Pharmaceuticals Inc., USA | 59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c | 2024-11-26 | Boxed warning, Warnings, Adverse reactions | deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Dr. Reddy's Laboratories Inc | 350dfc39-d03d-e221-22e9-3880728c955c | 2024-09-30 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Xiromed, LLC | 4c36bb5a-2552-46c1-8500-4ae783cffef1 | 2024-09-17 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| Deferasirox | DEFERASIROX | Teva Pharmaceuticals, Inc. | e9054806-2721-4736-9aef-81ffb8db75d1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | Deferasirox DEFERASIROX |
| DEFERASIROX | DEFERASIROX | Aurobindo Pharma Limited | c7f14819-1abc-4abf-b55b-cf89beaf124e | 2024-05-09 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX DEFERASIROX |
| DEFERASIROX | DEFERASIROX | Camber Pharmaceuticals, Inc. | eded6687-ba78-4117-a316-eec56d46a08a | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX DEFERASIROX |
| DEFERASIROX | DEFERASIROX | NorthStar Rx LLC | 57cf1650-88f9-474e-9e19-df451a15619d | 2023-12-29 | Boxed warning, Warnings, Adverse reactions | DEFERASIROX DEFERASIROX |
| deferasirox | DEFERASIROX | Sun Pharmaceutical Industries, Inc. | 4a2e1bd2-9f3a-40ec-94a2-bc76350d6d4b | 2023-12-26 | Boxed warning, Warnings, Adverse reactions | deferasirox DEFERASIROX |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61210 | ORIG | 2019-12-10 |