Application 009766
- Type
- NDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METICORTEN | PREDNISONE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | METICORTEN | PREDNISONE | TABLET;ORAL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N009766-001 | METICORTEN | PREDNISONE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N009766-002 | METICORTEN | PREDNISONE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-08 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||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 | N009766-002 | METICORTEN | 1MG **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 | N009766-001 | METICORTEN | 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 | N009766-002 | METICORTEN | 1MG **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 | N009766-001 | METICORTEN | 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 | N009766-002 | METICORTEN | 1MG **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 | N009766-001 | METICORTEN | 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 | N009766-002 | METICORTEN | 1MG **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 | N009766-001 | METICORTEN | 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 | N009766-002 | METICORTEN | 1MG **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 | N009766-001 | METICORTEN | 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 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009766-001 | METICORTEN | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N009766-002 | METICORTEN | 1MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009766-001 | METICORTEN | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N009766-002 | METICORTEN | 1MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N009766-001 | METICORTEN | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N009766-002 | METICORTEN | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… |
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 | REMEDYREPACK INC. | af5d0f73-2aef-4db1-ae25-6d465c9f0ca1 | 2026-08-07 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | Proficient Rx LP | eabbefb2-21a9-4745-8021-1aac1ece7f9d | 2026-08-01 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Par Health USA, LLC | 10fe5a3b-84dc-4600-87c2-b80c97ce18cf | 2026-07-31 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | REMEDYREPACK INC. | 5218e88b-468b-4d60-ab7e-78cca632b23a | 2026-07-30 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 19fdbf9f-3a64-b9fa-e063-6394a90af086 | 2026-07-29 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1a9f00ac-ec92-4d2c-e063-6394a90ac4f6 | 2026-07-29 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 25b5958b-c151-9200-e063-6394a90af52c | 2026-07-29 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | PD-Rx Pharmaceuticals, Inc. | 1349a022-639b-4494-99a2-1594c7c0f0e9 | 2026-07-21 | Warnings, Adverse reactions | PREDNISONE |
| PREDNISONE | PREDNISONE | NuCare Pharmaceuticals,Inc. | 288ecb6d-3b0b-db95-e063-6394a90a78ff | 2026-07-21 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Cardinal Health 107, LLC | cdc2b903-5d86-45c1-b97c-2da48445dbdd | 2026-07-17 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 6c0376c4-87cf-40dc-b140-a6aac75b64f7 | 2026-07-13 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 931171e2-0bdb-451e-b737-72ce3ffbed53 | 2026-07-13 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Bryant Ranch Prepack | 55aedced-d945-4bd2-9aa8-0f18b89a0e7f | 2026-07-13 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | ANI Pharmaceuticals, Inc. | f05eb734-07e7-491c-b2e9-aae340e03750 | 2026-07-10 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Unit Dose Solutions, Inc. | 5590d36d-dbe7-1c78-e063-6294a90ad2d4 | 2026-07-01 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | Amneal Pharmaceuticals NY LLC | 03228706-92b9-43c9-8d73-c73aa124c58d | 2026-06-30 | Warnings, Adverse reactions | PREDNISONE |
| PredniSONE | PREDNISONE | St. Mary's Medical Park Pharmacy | 16ee689e-c7a9-3a5a-e063-6394a90a6ea2 | 2026-06-22 | Warnings, Adverse reactions | PREDNISONE |
| prednisone | PREDNISONE | St. Mary's Medical Park Pharmacy | e4437eec-eadf-7c8b-e053-2a95a90af846 | 2026-06-21 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | St. Mary's Medical Park Pharmacy | 1b3ea4cc-5bc6-ae47-e063-6294a90af13d | 2026-06-15 | Warnings, Adverse reactions | PREDNISONE |
| Prednisone | PREDNISONE | Redpharm Drug | 5407a00b-1bfb-e37d-e063-6294a90a6c41 | 2026-06-12 | Warnings, Adverse reactions | PREDNISONE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.