Application 080209
- Type
- ANDA
- Sponsor
- CONTRACT PHARMACAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISONE | PREDNISONE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080209-001 | PREDNISONE | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 |
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 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080209-001 | PREDNISONE | 5MG | TABLET / ORAL | Approved before 1982 | 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 | Bryant Ranch Prepack | fbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c5 | 2026-05-04 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Aphena Pharma Solutions - Tennessee, LLC | 18818282-68aa-82e9-e063-6394a90aef54 | 2026-05-01 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Proficient Rx LP | 4b37ada5-1f22-46d5-a794-fd1477c0eb9b | 2026-05-01 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | e4c1c8c5-0aa1-4531-aa7a-8567ac8dcba8 | 2026-04-29 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| PREDNISONE | PREDNISONE | Coupler LLC | 50734a48-807d-cc00-e063-6294a90a4dae | 2026-04-27 | Warnings, Adverse reactions | PREDNISONE PREDNISONE |
| prednisone | PREDNISONE | Sportpharm LLC | 5dde7256-d3b8-400d-a0eb-c60078bfc5d9 | 2026-04-24 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | Amneal Pharmaceuticals NY LLC | 0740ef68-7641-432e-bd46-4710687fc9d7 | 2026-04-14 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | REMEDYREPACK INC. | 4bd86b2f-75cb-4711-85e2-b81ed947cb13 | 2026-04-13 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | e9a74862-6a3b-4247-837a-389761b5c352 | 2026-04-13 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | e47a0448-331f-4846-8e63-c52c3afa274b | 2026-04-13 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | b540f4af-8f07-4c56-b151-d759440c514a | 2026-04-13 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | Bryant Ranch Prepack | 70d05ed7-5c4e-4cd1-84cd-0dbe90692c54 | 2026-04-09 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | af5d0f73-2aef-4db1-ae25-6d465c9f0ca1 | 2026-04-08 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Northwind Health Company, LLC | fbd3f0c3-06b3-c9b4-e053-6294a90a6fdd | 2026-04-07 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 6b360c1f-c862-47ee-a40e-3903c2d6162f | 2026-04-06 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e | 2026-03-27 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 3befbdc5-7d20-41b6-ad80-98e1c6b8caf5 | 2026-03-27 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | 53c66f70-58fd-4d4c-b054-e5cefdc0c637 | 2026-03-26 | Warnings, Adverse reactions | PREDNISONE PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | d6df3295-3118-49af-be05-b1fab0d4adaa | 2026-03-25 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 10 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 14d50f54-410b-45b2-a639-31498ceaf854 | 2026-03-25 | Warnings, Adverse reactions | PREDNISONE |