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002 | DELTASONE | PREDNISONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DELTASONE | PREDNISONE | TABLET;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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006 | DELTASONE | PREDNISONE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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007 | DELTASONE | PREDNISONE | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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008 | DELTASONE | PREDNISONE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N009986-002 | DELTASONE | PREDNISONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-005 | DELTASONE | PREDNISONE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-006 | DELTASONE | PREDNISONE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-007 | DELTASONE | PREDNISONE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009986-008 | DELTASONE | PREDNISONE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 Tablets, USP, 20 mg | PREDNISONE | Bryant Ranch Prepack | 0e55a02d-2de4-42c4-adc2-49536b899225 | 2025-12-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 10 mg | PREDNISONE | Bryant Ranch Prepack | 61dab6c2-4019-4d7c-bc8b-3a0a463beefc | 2025-12-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | Bryant Ranch Prepack | 53bd04e8-6cbd-45f6-ac59-53fd3005a221 | 2025-12-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 10 mg | PREDNISONE | Bryant Ranch Prepack | 8520622e-c0e3-4226-be84-e332ab98e6a7 | 2025-12-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | Bryant Ranch Prepack | 5e5c81bf-7cbb-4f02-b107-16efe3d353ee | 2025-12-03 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | QPharma, Inc. | c0e147a8-36a9-1e61-e053-2a95a90afd62 | 2025-12-01 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Marlex Pharmaceuticals, Inc. | f499197b-b9b7-1707-e053-2a95a90a0932 | 2025-11-21 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 8f9a581c-5fef-4089-aa94-7dc81ec5b566 | 2025-11-10 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 871540d3-39c3-460c-a855-3aeabfd87267 | 2025-11-10 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Coupler LLC | 41e6f1c3-d225-0ff0-e063-6394a90ace88 | 2025-10-24 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | Bryant Ranch Prepack | 83e825cc-fb19-48b9-9f15-6aba6b1cef57 | 2025-10-20 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 5b2f4fa9-817c-43c9-ac9a-750ab1d1f66f | 2025-10-20 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | c21be016-6b25-4e09-b253-23b58884ccb6 | 2025-10-14 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Direct_Rx | 24882e23-c05f-f2ee-e063-6294a90a536f | 2025-10-13 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 80705a8a-f007-4a18-82a6-a73733d57ea2 | 2025-10-12 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 43a4b2eb-f2cd-410f-9719-577fdc4ad5de | 2025-10-12 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | A-S Medication Solutions | 6f326242-786c-44b5-9317-f5fb0485d8e2 | 2025-10-12 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 10 mg | PREDNISONE | Bryant Ranch Prepack | 95b7de4c-9c69-45f6-9221-a2c87c441b04 | 2025-10-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 5 mg | PREDNISONE | Bryant Ranch Prepack | 419058f7-7f30-41a1-964b-8eaa69290dea | 2025-10-03 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE Tablets, USP, 20 mg | PREDNISONE | Bryant Ranch Prepack | b42adc18-21cc-4fe0-bf7d-fb76f4cda215 | 2025-10-03 | Warnings, Adverse reactions | PREDNISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.