Application 209191
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BORTEZOMIB | BORTEZOMIB | POWDER;INTRAVENOUS, SUBCUTANEOUS | 2.5MG/VIAL | Yes | No |
| 002 | BORTEZOMIB | BORTEZOMIB | POWDER;INTRAVENOUS, SUBCUTANEOUS | 1MG/VIAL | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209191-001 | BORTEZOMIB | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2022-05-02 |
| N209191-002 | BORTEZOMIB | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2022-05-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N209191-001 | AP |
| N209191-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2021-03-12 10:30 UTC | 2021-03 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209191-001 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-07-12 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N209191-002 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD | 2018-12-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2022-05-02 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209191-001 | BORTEZOMIB | 1MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2022-05-02 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209191-002 | BORTEZOMIB | 2.5MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2022-05-02 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N209191-001 | AP | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | N209191-002 | AP | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N209191-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N209191-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209191-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209191-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209191-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209191-002 | AP | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209191-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209191-002 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | 9fdf6169-699f-40eb-bda1-760253062b3c | 2023-02-27 | Warnings, Adverse reactions | 209191 NDA209191 0409-1703 0409-1704 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-1703 | BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | NDA | Current |
| 0409-1703 | BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | NDA | Current |
| 0409-1704 | BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | NDA | Current |
| 0409-1704 | BORTEZOMIB | BORTEZOMIB | Hospira, Inc. | NDA | Current |