Application 211530
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 25MG/ML | No | No |
| 002 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 100MG/4ML | No | No |
| 003 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 200MG/8ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211530-001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | |
| N211530-002 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | |
| N211530-003 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-12-15 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-12-15 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-12-15 | 3bdfa0b2c4d7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211530-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211530-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211530-003 | BENDAMUSTINE HYDROCHLORIDE | 200MG/8ML (25MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2022-12-15 | 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 |
|---|---|---|---|---|---|---|
| Bendamustine | BENDAMUSTINE HCL | Meitheal Pharmaceuticals Inc. | 40f6f58d-d9ac-4f65-9fc7-16984bf1f180 | 2026-05-11 | Warnings, Adverse reactions | Bendamustine |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.