Application 218349
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EDARAVONE | EDARAVONE | INJECTABLE;INJECTION | 30MG/100ML(0.3MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218349-001 | EDARAVONE | EDARAVONE | 30MG/100ML (0.3MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-07-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218349-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218349-001 | EDARAVONE | 30MG/100ML (0.3MG/ML) | SOLUTION / INTRAVENOUS | AP | 2026-07-22 | caaa826d4ba7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A218349-001 | AP | 1 | caaa826d4ba7… |
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 |
|---|---|---|---|---|---|---|
| edaravone | EDARAVONE | XGen Pharmaceuticals DJB, Inc. | a8245a98-2ccb-4062-b865-3aa348351b48 | 2026-05-28 | Warnings, Adverse reactions | edaravone EDARAVONE |
| RADICAVA ORS | EDARAVONE | Shionogi Inc. | 0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11 | 2026-05-05 | Warnings, Adverse reactions | EDARAVONE |
| Edaravone | EDARAVONE | Piramal Critical Care Inc. | 19862ae9-d6e1-70e6-e063-6394a90ae749 | 2025-10-07 | Warnings, Adverse reactions | Edaravone EDARAVONE |
| edaravone | EDARAVONE | Gland Pharma Limited | 46452eb5-db17-400d-b25b-11844a11e711 | 2024-05-07 | Warnings, Adverse reactions | edaravone EDARAVONE |
| Edaravone | EDARAVONE | Sandoz Inc | ae940bc6-1e6a-4b76-825c-bd2e1925e39a | 2023-10-01 | Warnings, Adverse reactions | Edaravone EDARAVONE |