Application 070147
- Type
- ANDA
- Sponsor
- PURACAP PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | 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 |
|---|---|---|---|---|---|---|---|
| A070147-001 | ALLOPURINOL | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 |
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 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A070147-001 | ALLOPURINOL | 300MG | TABLET / ORAL | 1985-12-10 | f41ea6bd6efb… |
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 | f99f4637-4d67-4b3c-8741-b775a9d0bde1 | 2022-11-11 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Proficient Rx LP | b20c6ed4-6b94-4a1b-b448-e910856fa825 | 2022-08-01 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Proficient Rx LP | 06cf0f4b-aef0-472e-b5c0-56e0c35354f2 | 2022-06-01 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 278df77c-3a9c-4c7d-ba8f-eb33f6335ef4 | 2022-05-11 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Gland Pharma Limited | 4839e842-511e-4c72-9153-2b7e4e1954e2 | 2022-03-23 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Aloprim | ALLOPURINOL | Mylan Institutional LLC | 10cc918f-aa44-415b-932d-2404695ac449 | 2022-02-18 | Warnings, Adverse reactions | ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 3dc4980c-8062-4239-a860-63888cabee46 | 2021-08-03 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Proficient Rx LP | d94f6643-621f-45ed-b2dc-26f84c5626ae | 2020-02-01 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | bb8f09b6-c9f5-4deb-81e1-8d743e622126 | 2019-03-26 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | 3f5905f1-243e-4880-ad1c-d34064f17356 | 2019-01-09 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Coupler LLC | 65171cf0-8486-1ca6-e053-2991aa0ab91f | 2018-04-18 | Allopurinol ALLOPURINOL | |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | aea483a7-4ce7-4fe5-936c-fd876b4fa3a8 | 2017-10-11 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
| Allopurinol | ALLOPURINOL | Aphena Pharma Solutions - Tennessee, LLC | ae821c68-626a-474c-b81d-ce75d9795b3c | 2016-08-15 | Warnings, Adverse reactions | Allopurinol ALLOPURINOL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.