Application 008126
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORTISONE ACETATE | CORTISONE ACETATE | TABLET;ORAL | 25MG | No | No |
| 002 | CORTISONE ACETATE | CORTISONE ACETATE | INJECTABLE;INJECTION | 25MG/ML | No | No |
| 003 | CORTISONE ACETATE | CORTISONE ACETATE | TABLET;ORAL | 5MG | No | No |
| 004 | CORTISONE ACETATE | CORTISONE ACETATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N008126-001 | CORTISONE ACETATE | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | ||
| N008126-002 | CORTISONE ACETATE | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N008126-003 | CORTISONE ACETATE | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | ||
| N008126-004 | CORTISONE ACETATE | CORTISONE ACETATE | 10MG | TABLET / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008126-001 | CORTISONE ACETATE | 25MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008126-002 | CORTISONE ACETATE | 25MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008126-003 | CORTISONE ACETATE | 5MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N008126-004 | CORTISONE ACETATE | 10MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Cortisone Acetate | CORTISONE ACETATE | Chartwell RX, LLC | cc158d11-f356-4696-8b73-5d2681dcbcf2 | 2025-06-06 | Warnings, Adverse reactions | Cortisone Acetate CORTISONE ACETATE |
| Cortisone aceticum | CORTISONE ACETATE | Boiron | 68f7a30a-e372-6ee9-e053-2a91aa0a6ddf | 2023-11-13 | CORTISONE ACETATE | |
| Cortisone aceticum | CORTISONE ACETATE | Boiron | 85424b40-5c2b-421d-e053-2991aa0a7771 | 2023-11-13 | CORTISONE ACETATE | |
| Cortisone aceticum | CORTISONE ACETATE | Boiron | 85426060-5630-aaa0-e053-2a91aa0af8d4 | 2023-04-11 | CORTISONE ACETATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.