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002 | DELTASONE | PREDNISONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DELTASONE | PREDNISONE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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006 | DELTASONE | PREDNISONE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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007 | DELTASONE | PREDNISONE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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008 | DELTASONE | PREDNISONE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N009986-002 | DELTASONE | PREDNISONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-005 | DELTASONE | PREDNISONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-006 | DELTASONE | PREDNISONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-007 | DELTASONE | PREDNISONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-008 | DELTASONE | PREDNISONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 | 9a2d3bee-610b-44dc-8266-869aaf08f0d1 | 2025-03-27 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | 309580a7-c3bb-e53b-e063-6394a90a1563 | 2025-03-17 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Bryant Ranch Prepack | f0354431-4968-4e34-969b-6985d73700a4 | 2025-02-25 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 1cb252f0-fd01-4620-bf88-2108fc1ea615 | 2025-02-19 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Golden State Medical Supply, Inc. | 1e05e071-0407-0970-e063-6294a90a6c65 | 2025-02-18 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | Advanced Rx of Tennessee, LLC | 2e62cf2e-dcbe-c15e-e063-6294a90a8168 | 2025-02-17 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Advanced Rx of Tennessee, LLC | 2e62cf2e-dcbf-c15e-e063-6294a90a8168 | 2025-02-17 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | Advanced Rx of Tennessee, LLC | 2e630aa1-eccd-f5eb-e063-6294a90a4745 | 2025-02-17 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Coupler LLC | 2d99223a-853a-7640-e063-6394a90a260a | 2025-02-07 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Preferred Pharmaceuticals Inc. | 94d82acb-ff31-492f-bd51-b23e15d881d6 | 2025-01-23 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Direct_Rx | fd8eb82e-52df-c368-e053-6294a90ac6b0 | 2025-01-22 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | af863b9e-964b-3b1e-e053-2995a90ab93a | 2024-12-31 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx of Tennessee, LLC | af861c38-3293-13fe-e053-2995a90a9932 | 2024-12-31 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbf833-b929-8c85-e053-2995a90a5896 | 2024-12-31 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | e1e7d14b-80b2-f57e-e053-2995a90af112 | 2024-12-31 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Advanced Rx Pharmacy of Tennessee, LLC | b3dbff9f-610f-7782-e053-2a95a90a71c1 | 2024-12-31 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | NuCare Pharmaceuticals, Inc. | 28f2733e-963e-f0e0-e063-6394a90a0a9d | 2024-12-10 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | NuCare Pharmaceuticals,Inc. | 1b42449a-2be8-e4fb-e063-6394a90aff98 | 2024-11-08 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | A-S Medication Solutions | 3bfdc4d7-ba8e-422a-96e3-3c3ba587eab1 | 2024-11-08 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Direct_Rx | 26194836-90c9-6909-e063-6294a90a6f98 | 2024-11-04 | Warnings, Adverse reactions | PREDNISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.