Application 040364
- Type
- ANDA
- Sponsor
- NESHER PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISOLONE | PREDNISOLONE | SYRUP;ORAL | 15MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040364-001 | PREDNISOLONE | PREDNISOLONE | 15MG/5ML | SOLUTION / ORAL | 2002-04-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040364-001 | PREDNISOLONE | 15MG/5ML | SOLUTION / ORAL | 2002-04-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040364-001 | PREDNISOLONE | 15MG/5ML | SOLUTION / ORAL | 2002-04-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SOLUTION / ORAL | 2002-04-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040364-001 | PREDNISOLONE | 15MG/5ML | SOLUTION / ORAL | 2002-04-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A040364-001 | PREDNISOLONE | 15MG/5ML | SYRUP / ORAL | 2002-04-10 | 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 |
|---|---|---|---|---|---|---|
| Prednisolone | PREDNISOLONE ORAL | Tulex Pharmaceuticals Inc | 757b41c4-a0fe-4a09-8816-a4cdb7558f41 | 2026-07-08 | Warnings, Adverse reactions | Prednisolone |
| Prednisolone | PREDNISOLONE | A-S Medication Solutions | 35f0b197-c3ae-445a-8da7-9ffcd4472e05 | 2026-01-23 | Warnings, Adverse reactions | Prednisolone PREDNISOLONE |
| PREDNISOLONE | PREDNISOLONE | Zhejiang Xianju Pharmaceutical Co., Ltd. | 52e6e21d-94b8-41a0-8d13-371c0e66bcee | 2026-01-05 | Warnings, Adverse reactions | PREDNISOLONE PREDNISOLONE |
| Prednisolone | PREDNISOLONE ORAL | Chartwell Governmental & Specialty RX, LLC. | 2dac9898-6492-4f34-ad86-83a902e0fe0b | 2025-11-18 | Warnings, Adverse reactions | Prednisolone |
| Prednisolone | PREDNISOLONE ORAL SOLUTION | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | b079834f-9aa3-4db9-bd53-de28e8f81c04 | 2025-02-18 | Warnings, Adverse reactions | Prednisolone |
| Prednisolone | PREDNISOLONE | PAI Holdings, LLC dba PAI Pharma | cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3 | 2024-08-19 | Warnings, Adverse reactions | Prednisolone PREDNISOLONE |
| PREDNISOLONE | PREDNISOLONE | Hisun Pharmaceuticals USA, Inc. | 16d4e064-66d3-4497-8c7d-3aa355f91e1d | 2024-08-15 | Warnings, Adverse reactions | PREDNISOLONE PREDNISOLONE |
| Prednisolone | PREDNISOLONE | Chartwell RX, LLC | 2e965355-f7f2-4dd3-9c5c-1524c6f39c91 | 2024-06-17 | Warnings, Adverse reactions | Prednisolone PREDNISOLONE |
| Prednisolone | PREDNISOLONE ORAL | Chartwell RX, LLC | aa40f582-cced-4e6e-90f0-10ab310ab2a7 | 2024-06-03 | Warnings, Adverse reactions | Prednisolone |
| PREDNISOLONE | PREDNISOLONE | Aurobindo Pharma Limited | 070f1937-50a5-457f-bef5-4e597014e26d | 2024-02-16 | Warnings, Adverse reactions | PREDNISOLONE PREDNISOLONE |
| PrednisoLONE | PREDNISOLONE | Lannett Company, Inc. | 86652e2d-664a-4388-a611-c2a9aa4a4bc8 | 2024-02-14 | Warnings, Adverse reactions | PrednisoLONE PREDNISOLONE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 58177-910 | Prednisolone | Prednisolone | ETHEX Corporation | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 7638 | ORIG | 2003-04-08 |