Application 217748
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALLOPURINOL | ALLOPURINOL | TABLET;ORAL | 100MG | No | No |
| 002 | ALLOPURINOL | ALLOPURINOL | TABLET;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217748-001 | ALLOPURINOL | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | |
| A217748-002 | ALLOPURINOL | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217748-001 | AB |
| A217748-002 | AB |
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 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | 9b2671bbb829… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217748-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2023-08-03 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217748-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2023-08-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217748-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217748-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217748-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217748-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217748-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217748-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217748-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217748-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217748-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217748-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217748-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217748-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217748-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217748-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217748-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217748-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217748-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217748-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217748-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217748-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217748-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217748-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217748-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217748-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217748-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217748-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217748-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217748-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217748-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217748-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217748-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217748-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217748-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217748-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217748-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217748-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217748-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A217748-002 | AB | 1 | 9b2671bbb829… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217748-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217748-002 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| ALLOPURINOL | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 583df4b8-a1d4-01ed-e063-6394a90af007 | 2026-08-04 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 5644814c-3f61-5338-e063-6294a90ad6c9 | 2026-07-10 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Northwind Health Company, LLC | 4deeebe3-fccc-2082-e063-6294a90a0c78 | 2026-05-11 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Bryant Ranch Prepack | d9961781-cfe8-459b-920d-eb000d45d41f | 2026-02-13 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | REMEDYREPACK INC. | 20015399-43f8-4917-8ffe-dd8055c75712 | 2026-02-05 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | XLCare Pharmaceuticals Inc. | fc7973c8-d846-4eca-ab0d-d30228035ba2 | 2026-01-08 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | A-S Medication Solutions | c476ae27-fa13-480c-8d02-58c2c2904b84 | 2025-11-26 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | A-S Medication Solutions | 8047206e-305b-44d2-aa61-dff0366e7675 | 2025-11-26 | Warnings, Adverse reactions | 217748 ANDA217748 |
| Allopurinol | ALLOPURINOL | Direct_Rx | 426262e6-8219-c825-e063-6294a90a21a9 | 2025-10-30 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | A-S Medication Solutions | 78978de2-1842-4570-9d11-67f13cc37ad5 | 2025-10-14 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | A-S Medication Solutions | 5955ca3f-9383-4025-ac58-90394716493a | 2025-10-14 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Bryant Ranch Prepack | e453a5e0-44c3-4eb5-a8d0-7c02157d2f8c | 2025-10-02 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Preferred Pharmaceuticals Inc. | d83fec65-396a-40bd-8ee8-828d8930ea41 | 2025-09-22 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Advanced Rx of Tennessee, LLC | 36c1c908-1eed-ed2a-e063-6294a90a16f9 | 2025-05-29 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Preferred Pharmaceuticals Inc. | 09d34fab-250c-496a-93f5-c8d9f52a2276 | 2025-04-23 | Warnings, Adverse reactions | 217748 ANDA217748 |
| Allopurinol | ALLOPURINOL | A-S Medication Solutions | d9a20bf5-15b9-4643-b829-40eacd4e849d | 2024-10-21 | Warnings, Adverse reactions | 217748 ANDA217748 |
| Allopurinol | ALLOPURINOL | A-S Medication Solutions | 869e09f7-fb72-4e15-8d4b-849e86ebc6fd | 2024-10-21 | Warnings, Adverse reactions | 217748 ANDA217748 |
| ALLOPURINOL | ALLOPURINOL | Camber Pharmaceuticals, Inc. | 60750373-7146-455a-8d12-d0e32d2d4bc8 | 2024-10-17 | Warnings, Adverse reactions | 217748 ANDA217748 |