Application 215441
- Type
- NDA
- Sponsor
- INTAS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BORTEZOMIB | BORTEZOMIB | SOLUTION;INTRAVENOUS | 2.5MG/ML (2.5MG/ML) | Yes | Yes |
| 002 | BORTEZOMIB | BORTEZOMIB | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| N215441-001 | BORTEZOMIB | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | |
| N215441-002 | BORTEZOMIB | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | a72a2bbeb626… |
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 |
|---|---|---|---|---|---|---|
| Bortezomib | BORTEZOMIB | Sintetica US LLC | d79a71ec-b46d-4961-ad05-8980915cba94 | 2023-10-09 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | 9fdf6169-699f-40eb-bda1-760253062b3c | 2023-02-27 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Novadoz Pharmaceuticals LLC | d41340c2-7fe8-42b2-aaa5-c9f9b0e9b50e | 2022-07-20 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | BluePoint Laboratories | 12500f21-8e2f-4bcd-861e-4dfca843da2e | 2022-05-16 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Qilu Pharmaceutical Co., Ltd. | aef02171-bf8a-43ad-b40c-7642623f9802 | 2022-05-09 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Zydus Lifesciences Limited | 582c7c0d-fa25-4586-8157-a1e2653d72d9 | 2022-05-05 | BORTEZOMIB BORTEZOMIB | |
| Bortezomib | BORTEZOMIB | Pharmascience Inc. | 191d231a-1fbd-4a65-9d33-d5dc03bac381 | 2022-05-02 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Waverley Pharma Inc | a73d7ea7-d068-4d25-b368-fc3db1898be2 | 2022-04-13 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| bortezomib | BORTEZOMIB | Hikma Pharmaceuticals USA Inc. | 854be921-5fd9-482a-8432-a0c0241625f8 | 2021-11-22 | Warnings, Adverse reactions | bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | MAIA Pharmaceuticals, Inc. | c40e6a28-d577-43d4-bca6-bef28da1d580 | 2021-09-22 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.