Application 040362
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREDNISONE | PREDNISONE | TABLET;ORAL | 10MG | No | No |
| 002 | PREDNISONE | PREDNISONE | TABLET;ORAL | 5MG | No | No |
| 003 | PREDNISONE | PREDNISONE | TABLET;ORAL | 20MG | No | No |
| 004 | PREDNISONE | PREDNISONE | TABLET;ORAL | 2.5MG | No | No |
| 005 | PREDNISONE | PREDNISONE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040362-001 | PREDNISONE | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | |
| A040362-002 | PREDNISONE | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | |
| A040362-003 | PREDNISONE | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | |
| A040362-004 | PREDNISONE | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | |
| A040362-005 | PREDNISONE | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040362-001 | AB |
| A040362-002 | AB |
| A040362-003 | AB |
| A040362-004 | AB |
| A040362-005 | AB |
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 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-001 | PREDNISONE | 10MG | TABLET / ORAL | AB | 2001-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-002 | PREDNISONE | 5MG | TABLET / ORAL | AB | 2001-08-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-003 | PREDNISONE | 20MG | TABLET / ORAL | AB | 2005-06-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-004 | PREDNISONE | 2.5MG | TABLET / ORAL | AB | 2023-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-005 | PREDNISONE | 50MG | TABLET / ORAL | AB | 2023-04-17 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040362-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040362-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040362-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040362-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040362-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040362-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040362-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040362-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040362-005 | AB | 1 | 5bbf6a4d5a75… |
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 | A-S Medication Solutions | 74102cc5-7a1a-4a0f-a07f-a4b0f86bcabf | 2025-07-23 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | dc94273f-af06-4bd5-9ce3-ce0a0f36587b | 2025-07-03 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | af863b9e-964b-3b1e-e053-2995a90ab93a | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 80425-0069 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbf833-b929-8c85-e053-2995a90a5896 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 80425-0106 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | e1e7d14b-80b2-f57e-e053-2995a90af112 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 80425-0193 |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbff9f-610f-7782-e053-2a95a90a71c1 | 2024-12-31 | Warnings, Adverse reactions | 040362 ANDA040362 80425-0105 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62fdf3c2-cfa9-d573-e053-2a91aa0a833b | 2024-08-14 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62ec965c-e682-9920-e053-2a91aa0adcdb | 2024-08-14 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 62ff1da3-79aa-676a-e053-2991aa0a4a9f | 2024-07-19 | Warnings, Adverse reactions | 040362 ANDA040362 68071-3143 |
| Prednisone | PREDNISONE | A-S Medication Solutions | 751b7f62-f92b-4b7c-a588-2c882d5d1ce3 | 2024-06-25 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | cb1b0dc0-6916-4e6f-9775-26ea0f593f83 | 2024-06-03 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63106192-35d5-6989-e053-2991aa0aa714 | 2024-04-25 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | A-S Medication Solutions | 5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2 | 2024-04-02 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63102d75-9b2b-84a9-e053-2a91aa0a317d | 2024-02-09 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Proficient Rx LP | 5961b1d4-6a4c-452f-b3f1-c99f3a9a6445 | 2023-09-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Asclemed USA, Inc. | dc663fd3-b149-48ae-a3f3-6abaa4808cc6 | 2020-08-28 | Warnings, Adverse reactions | 040362 ANDA040362 76420-068 76420-069 76420-067 |
| Prednisone | PREDNISONE | Proficient Rx LP | e4555299-af68-416f-8999-9bb703a45e77 | 2019-10-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
| Prednisone | PREDNISONE | Proficient Rx LP | 7c650dc8-43f6-4257-81ed-c93b00202d06 | 2019-10-01 | Warnings, Adverse reactions | 040362 ANDA040362 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68071-1777 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1779 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1779 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1779 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3143 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3143 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3143 | Prednisone | Prednisone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6440 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6440 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6440 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6440 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7372 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7372 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7372 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7372 | Prednisone | Prednisone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9309 | Prednisone | Prednisone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9309 | Prednisone | Prednisone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9309 | Prednisone | Prednisone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0242 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0242 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0242 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0632 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0948 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0948 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-0948 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2486 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2486 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2486 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2555 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-2555 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70882-117 | Prednisone | Prednisone | Cambridge Therapeutics Technologies, LLC | ANDA | Current |
| 70934-095 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-095 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-095 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-095 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-095 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-096 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-096 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-096 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-096 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-096 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-101 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-101 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-101 | Prednisone | Prednisone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0335 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0335 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0508 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0508 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0623 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-0623 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1574 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-2051 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-2051 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 72789-235 | Prednisone | Prednisone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-235 | Prednisone | Prednisone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-235 | Prednisone | Prednisone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76420-067 | Prednisone | Prednisone | Asclemed USA, Inc. | ANDA | Current |
| 76420-068 | Prednisone | Prednisone | Asclemed USA, Inc. | ANDA | Current |
| 76420-069 | Prednisone | Prednisone | Asclemed USA, Inc. | ANDA | Current |
| 80425-0069 | Deltasone 5mg | Prednisone 5mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0069 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0069 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0105 | Prednisone | Prednisone 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0105 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0105 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0106 | Prednisone | Prednisone 5mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0106 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0106 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0193 | Prednisone | Prednisone | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29940 | ORIG | 2001-08-29 |