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| BORTEZOMIB | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | |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BORTEZOMIB | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 |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| N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 84e616aacf4f… | |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N215441-002 | BORTEZOMIB | 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | 84e616aacf4f… | |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| N215441-001 | BORTEZOMIB | 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAVENOUS | RLD | 2022-07-26 | caaa826d4ba7… | |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 | Apotex Corp | b605b541-4bfd-db3e-9710-11c27f6dee6c | 2026-09-09 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Avenacy, LLC | decb5d94-2ea2-48d8-b08b-3196b24c0ed3 | 2026-01-09 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Gland Pharma Limited | cd698074-da21-4b53-8f6b-241535a8d598 | 2026-01-08 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Ningbo Shuangcheng Pharmaceutical Co., Ltd. | b17ca681-59a5-4af7-98a4-953b38379893 | 2025-12-30 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Eugia US LLC | ed526447-a4fe-403b-8f08-21ce1b2fa8b7 | 2025-12-23 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
| Bortezomib | BORTEZOMIB | BluePoint Laboratories | 10f60367-0476-4acd-861b-90c18d4b8164 | 2025-11-20 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| VELCADE | BORTEZOMIB | Takeda Pharmaceuticals America, Inc. | 1521d321-e724-4ffc-adad-34bf4f44fac7 | 2025-08-28 | Warnings, Adverse reactions | BORTEZOMIB |
| Bortezomib | BORTEZOMIB | BluePoint Laboratories | c6b620c6-f3d6-4ff3-b46a-50a66e6d41dd | 2025-07-31 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Meitheal Pharmaceuticals Inc. | 322e315f-dd94-475f-94f4-4d86a7eb5590 | 2025-07-23 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORUZU | BORTEZOMIB | Amneal Pharmaceuticals LLC | b92628dd-fa09-4c3a-b6a3-66426025807c | 2025-07-05 | Warnings, Adverse reactions | BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Somerset Therapeutics LLC | dc737d3d-2a4e-448a-ad70-e013065c411c | 2025-05-10 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | NorthStar RxLLC | 3f02670b-5683-780c-9d38-5d8f0ef43a14 | 2025-05-06 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Sagent Pharmaceuticals | 945fbaf0-7a79-4676-aa90-e9a213c0654f | 2025-05-05 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Fresenius Kabi USA, LLC | 3494c357-a692-4e55-89e1-93532b0baef7 | 2025-03-27 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Zydus Pharmaceuticals USA Inc. | 0eb8daef-18da-43bb-b7c6-38c4c8b5dd80 | 2024-12-05 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Shilpa Medicare Limited | 61539d49-dc21-4576-8813-4bc8abf3868c | 2024-08-30 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Camber Pharmaceuticals, Inc. | 04aafa6a-a50d-4a47-a831-be8e8bb992ac | 2024-07-22 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Dr.Reddy's Laboratories, Inc. | 664bee24-7af2-2099-ac99-5dd71a1e5a14 | 2024-05-17 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| Bortezomib | BORTEZOMIB | Hospira, Inc. | 41e3de39-8278-4a75-badf-601e4602080d | 2024-04-09 | Warnings, Adverse reactions | Bortezomib BORTEZOMIB |
| BORTEZOMIB | BORTEZOMIB | Eugia US LLC | 76c7c3a5-fd2f-403f-85fd-65a64538eee7 | 2023-10-20 | Warnings, Adverse reactions | BORTEZOMIB BORTEZOMIB |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.