Application 090637
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A090637-001 | ALLOPURINOL | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | ||
| A090637-002 | ALLOPURINOL | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 |
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 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | 2011-03-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | 2011-03-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090637-001 | ALLOPURINOL | 100MG | TABLET / ORAL | AB | 2011-03-16 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090637-002 | ALLOPURINOL | 300MG | TABLET / ORAL | AB | 2011-03-16 | 782e0a99824c… |
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 | A090637-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090637-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090637-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090637-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090637-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090637-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090637-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090637-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090637-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090637-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090637-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090637-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090637-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090637-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090637-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090637-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090637-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090637-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090637-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090637-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090637-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090637-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090637-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090637-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090637-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090637-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090637-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090637-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090637-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090637-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090637-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090637-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090637-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090637-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090637-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090637-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090637-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090637-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090637-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090637-002 | AB | 1 | b00525d2431f… |
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 | ALLOPURINOL ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Sun Pharmaceutical Industries, Inc. | fd8f8b8b-f25e-46e9-969a-65363b66e09b | 2026-07-31 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Cardinal Health 107, LLC | ced59048-c147-4702-af32-2f9b517ed87a | 2026-07-24 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Cardinal Health 107, LLC | b6c5b5c0-b1cb-44c0-a849-5d317e6fa300 | 2026-07-21 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | REMEDYREPACK INC. | 55280a8a-cf23-405b-b698-95a4d8e3c699 | 2026-07-14 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 6341a72d-9c83-448c-871b-e800ad8f1547 | 2026-07-13 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| ALLOPURINOL | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 5644814c-3f61-5338-e063-6294a90ad6c9 | 2026-07-10 | Warnings, Adverse reactions | ALLOPURINOL ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Major Pharmaceuticals | 8c0f5af5-a453-4641-933f-ccb2625fca39 | 2026-06-24 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 156d743c-6324-44db-9230-21f762d64cfd | 2026-06-11 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | b943dbb1-7f54-434c-9439-8ce768d94ff4 | 2026-06-10 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | St. Mary's Medical Park Pharmacy | 0f8b97d0-4d0b-9f4a-e063-6294a90a033f | 2026-06-04 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | St. Mary's Medical Park Pharmacy | 00b27899-e68f-e9d9-e063-6394a90a88cb | 2026-06-03 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Major Pharmaceuticals | b630c1cb-d4b7-4f80-b252-5947c1887def | 2026-06-01 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | PD-Rx Pharmaceuticals, Inc. | b2ab2389-ccaf-487b-9985-50e3539e7617 | 2026-05-28 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | PD-Rx Pharmaceuticals, Inc. | 211e47c6-85b9-43e8-9e07-6cc4b8f708a0 | 2026-05-28 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | PD-Rx Pharmaceuticals, Inc. | f1c11f74-1de2-484c-b40b-d0013e8fd01a | 2026-05-27 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | PD-Rx Pharmaceuticals, Inc. | f130c9c0-45d8-42bc-a040-04bb077671f8 | 2026-05-27 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Rising Pharma Holdings, Inc. | 30ad5ba2-1cef-4933-b104-0597f6a2aaa2 | 2026-05-21 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 3bcd1381-34d9-4fa5-bfc5-2566cb7a7638 | 2026-05-21 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Bryant Ranch Prepack | 76ed9122-b845-423b-a6d5-a47b31743317 | 2026-05-19 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-545 | Allopurinol | Allopurinol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-547 | Allopurinol | Allopurinol | Blenheim Pharmacal, Inc. | ANDA | Current |
| 51655-038 | ALLOPURINOL | ALLOPURINOL | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0929 | Allopurinol | Allopurinol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1026 | Allopurinol | Allopurinol | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63304-539 | Allopurinol | Allopurinol | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-540 | Allopurinol | Allopurinol | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 68788-9331 | Allopurinol | Allopurinol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9832 | Allopurinol | Allopurinol | Preferred Pharmaceuticals, Inc. | ANDA | Current |