Application 089983
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISONE | PREDNISONE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089983-001 | PREDNISONE | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 |
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 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089983-001 | PREDNISONE | 10MG | TABLET / ORAL | 1989-01-12 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Prednisone | PREDNISONE | Northwind Health Company, LLC | f6cb7924-4190-f130-e053-6294a90a21fe | 2026-01-01 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Northwind Health Company, LLC | f2f1a2ea-fa1b-b4f1-e053-2995a90aa276 | 2026-01-01 | Warnings, Adverse reactions | prednisone PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | ab315be2-8d13-be25-e053-2995a90a5184 | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | 0f377d9f-b2f4-4dae-b503-5f963bea281f | 2026-01-01 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | dad4f191-8893-48e0-e053-2995a90ae864 | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | ca39fdfb-d110-6535-e053-2995a90a550a | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | da6fce58-0ef9-f3b1-e053-2995a90a1bec | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | da7f948f-8039-5f0d-e053-2a95a90ad0f0 | 2026-01-01 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Northwind Health Company, LLC | f7e523ab-d831-6acf-e053-6294a90a79a3 | 2026-01-01 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | f76db82a-826e-92b0-e053-6294a90a8ec6 | 2026-01-01 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | f77f4a5a-b307-84ff-e053-6294a90aba5b | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| prednisone | PREDNISONE | Northwind Health Company, LLC | e08ba8c5-5e26-6120-e053-2995a90a1364 | 2026-01-01 | Warnings, Adverse reactions | prednisone PREDNISONE |
| PredniSONE | PREDNISONE | Northwind Health Company, LLC | c9f4711d-319c-d952-e053-2a95a90a3697 | 2026-01-01 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| prednisone | PREDNISONE | Northwind Health Company, LLC | fc4cd6f4-e01f-ad2d-e053-6294a90aebd6 | 2026-01-01 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | American Health Packaging | 5393d51e-816b-4761-8e8a-7eadcf74245f | 2025-12-29 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Redpharm Drug | 0ab0e81c-8170-6805-e063-6294a90adfc0 | 2025-12-25 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | American Health Packaging | a0e8d1a2-8c82-4dc0-8c2f-9da84382f34e | 2025-12-23 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | e28359cf-0c21-487a-a1a3-d1c62cef88f9 | 2025-12-23 | Warnings, Adverse reactions | prednisone PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | 35de14e3-d748-46bd-a307-6a1a27c626a2 | 2025-12-17 | Warnings, Adverse reactions | PREDNISONE PREDNISONE |
| Prednisone delayed release | PREDNISONE | INA Pharmaceutics Inc | 463c7cd2-c973-5c6c-e063-6394a90a09a0 | 2025-12-17 | Warnings, Adverse reactions | PREDNISONE |