Application 212782
- Type
- NDA
- Sponsor
- SHILPA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BORTEZOMIB | BORTEZOMIB | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/1.4ML (2.5MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212782-001 | BORTEZOMIB | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 |
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 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | d06236e962d9… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N212782-001 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2024-08-26 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| BORUZU | BORTEZOMIB | Amneal Pharmaceuticals LLC | b92628dd-fa09-4c3a-b6a3-66426025807c | 2025-07-05 | Warnings, Adverse reactions | 212782 NDA212782 |
| Bortezomib | BORTEZOMIB | Shilpa Medicare Limited | 61539d49-dc21-4576-8813-4bc8abf3868c | 2024-08-30 | Warnings, Adverse reactions | 212782 NDA212782 |