Application 009986
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | DELTASONE | PREDNISONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | DELTASONE | PREDNISONE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | DELTASONE | PREDNISONE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | DELTASONE | PREDNISONE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 008 | DELTASONE | PREDNISONE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N009986-002 | DELTASONE | PREDNISONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-005 | DELTASONE | PREDNISONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-006 | DELTASONE | PREDNISONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-007 | DELTASONE | PREDNISONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-008 | DELTASONE | PREDNISONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009986-002 | DELTASONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009986-005 | DELTASONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009986-006 | DELTASONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009986-007 | DELTASONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N009986-008 | DELTASONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… |
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 | 72367ecf-579e-4ef9-8119-54fd46a079b6 | 2024-05-30 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Bryant Ranch Prepack | 7601e38d-b7d2-4292-b16e-abff32bb46b3 | 2024-05-29 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Bryant Ranch Prepack | 29c96865-48be-4898-81b7-a6fc9623d3b9 | 2024-05-28 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Proficient Rx LP | 94f8ec56-667e-4eda-832d-f2936f12dc36 | 2024-05-01 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63106192-35d5-6989-e053-2991aa0aa714 | 2024-04-25 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | NuCare Pharmaceuticals,Inc. | db4a13ff-546d-15b7-e053-2a95a90a6adf | 2024-04-23 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | 5c8ffc9d-3804-40d3-ae2c-1fbac7bdc8d2 | 2024-04-02 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Medsource Pharmaceuticals | 131780a0-31f3-6588-e063-6294a90a2f8e | 2024-03-07 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | NuCare Pharmaceuticals,Inc. | 1289c6d2-2707-baca-e063-6294a90a750d | 2024-02-29 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | 95cf05e5-1446-43f5-8447-c04877a74781 | 2024-02-27 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | ANI Pharmaceuticals, Inc. | 7335a293-992b-490c-ab8a-66a7ca1eea30 | 2024-02-16 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | 7b33767f-a520-4470-8f3f-4e86b38d615a | 2024-02-16 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | b1ac4c92-e1fd-4015-b172-0932790ae019 | 2024-02-16 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 63102d75-9b2b-84a9-e053-2a91aa0a317d | 2024-02-09 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | 410988ea-456a-454e-932c-fcbdbef04ba9 | 2024-01-18 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | A-S Medication Solutions | 44069d49-4cf4-4f1e-9fbd-b496c6ca81a1 | 2024-01-18 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 17278e0a-cbff-4a95-96ee-f34f7466faa0 | 2023-11-24 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Chartwell RX, LLC | 92483276-d55c-42c6-8bbc-27137ff25296 | 2023-09-06 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Proficient Rx LP | 6a0c1192-8ce4-466d-a0f3-d878d67349cf | 2023-09-01 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Proficient Rx LP | 5961b1d4-6a4c-452f-b3f1-c99f3a9a6445 | 2023-09-01 | Warnings, Adverse reactions | PREDNISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.