Application 089726
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISONE | PREDNISONE | SOLUTION;ORAL | 5MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089726-001 | PREDNISONE | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089726-001 | PREDNISONE | 5MG/5ML | SOLUTION / ORAL | 1988-08-02 | e64feba35796… |
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 | REMEDYREPACK INC. | 23b12d22-97d6-426e-bf9c-dd6c2ff77370 | 2026-08-26 | Warnings, Adverse reactions | prednisone PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 6b360c1f-c862-47ee-a40e-3903c2d6162f | 2026-08-21 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | Preferred Pharmaceuticals Inc. | 02158832-550b-4855-a5c5-6abbf13ed6f0 | 2026-08-20 | Warnings, Adverse reactions | PredniSONE PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | c60a07f9-ed9f-4434-a69d-2e2fea4843fd | 2026-08-20 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| Prednisone | PREDNISONE | REMEDYREPACK INC. | 746b0bcd-122e-4ea8-a824-28415073a38e | 2026-08-20 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 7ea7f6a9-78ef-42fe-baac-f817da3976fb | 2026-08-20 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Preferred Pharmaceuticals Inc. | 1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f | 2026-08-19 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | Preferred Pharmaceuticals Inc. | fa75f5ce-8a74-4873-811f-7d9d9beec08f | 2026-08-19 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | Preferred Pharmaceuticals Inc. | 930b5eea-3ec8-47df-a76d-1e0bc0b5c5b2 | 2026-08-19 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Preferred Pharmaceuticals, Inc. | f89bd1dc-88cd-4aef-a7ae-6310f38a3423 | 2026-08-19 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | Preferred Pharmaceuticals Inc. | ce7663a7-4c91-4790-aa43-96f259b3bb18 | 2026-08-19 | Warnings, Adverse reactions | prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | e47a0448-331f-4846-8e63-c52c3afa274b | 2026-08-11 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Cardinal Health 107, LLC | 568b8880-7997-4786-8c57-28816ce52655 | 2026-08-07 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | af5d0f73-2aef-4db1-ae25-6d465c9f0ca1 | 2026-08-07 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | Par Health USA, LLC | 10fe5a3b-84dc-4600-87c2-b80c97ce18cf | 2026-07-31 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | 5218e88b-468b-4d60-ab7e-78cca632b23a | 2026-07-30 | Warnings, Adverse reactions | prednisone PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 19fdbf9f-3a64-b9fa-e063-6394a90af086 | 2026-07-29 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1a9f00ac-ec92-4d2c-e063-6394a90ac4f6 | 2026-07-29 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 25b5958b-c151-9200-e063-6394a90af52c | 2026-07-29 | Warnings, Adverse reactions | Prednisone PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1349a022-639b-4494-99a2-1594c7c0f0e9 | 2026-07-21 | Warnings, Adverse reactions | Prednisone PREDNISONE |