Application 205447
- Type
- ANDA
- Sponsor
- BRECKENRIDGE PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER;IV (INFUSION) | 25MG/VIAL | No | No |
| 002 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER;IV (INFUSION) | 100MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205447-001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | ||
| A205447-002 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | 2023-02-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / INTRAVENOUS | AP | 2023-02-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / INTRAVENOUS | AP | 2023-02-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205447-001 | BENDAMUSTINE HYDROCHLORIDE | 25MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205447-002 | BENDAMUSTINE HYDROCHLORIDE | 100MG/VIAL | POWDER / IV (INFUSION) | AP | 2023-02-14 | a67488948f0b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205447-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205447-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205447-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205447-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205447-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205447-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205447-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205447-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205447-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205447-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205447-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205447-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205447-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205447-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205447-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205447-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A205447-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A205447-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A205447-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A205447-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205447-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205447-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205447-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205447-002 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205447-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205447-002 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205447-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205447-002 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A205447-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A205447-002 | AP | 1 | 053a50430f4f… |
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 HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | Avyxa Pharma, LLC | f359e7c6-d104-457d-a7fe-597c74440353 | 2026-05-14 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE |
| Bendamustine Hydrochloride | BENDAMUSTINE HYDROCHLORIDE | Apotex Corp | 085dd54c-4212-d879-afef-ee52732a48c0 | 2025-09-16 | Warnings, Adverse reactions | Bendamustine Hydrochloride BENDAMUSTINE HYDROCHLORIDE |
| VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE | Azurity Pharmaceuticals, Inc. | 4df6548f-c4ad-4eb2-a54f-19766a3d90ca | 2025-04-03 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE |
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | Baxter Healthcare Corporation | 766b73e2-49bb-47f9-bbb1-44cfa1a3197e | 2025-02-10 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE |
| BELRAPZO | BENDAMUSTINE HYDROCHLORIDE | Eagle Pharmaceuticals, Inc | 9759a4ae-82ca-40cf-9c02-e1cadb21cbdc | 2024-09-23 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE |
| bendamustine hydrochloride | BENDAMUSTINE HYDROCHLORIDE | Accord Healthcare, Inc. | 33867f0f-f317-1fd0-e054-00144ff8d46c | 2024-07-18 | Warnings, Adverse reactions | bendamustine hydrochloride BENDAMUSTINE HYDROCHLORIDE |
| bendamustine hydrochloride | BENDAMUSTINE HYDROCHLORIDE | BluePoint Laboratories | 0df025d2-c093-427a-b599-f605e71fe835 | 2024-03-29 | Warnings, Adverse reactions | bendamustine hydrochloride BENDAMUSTINE HYDROCHLORIDE |
| VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE | Slayback Pharma LLC | cbcc6eb7-aa62-4599-af49-05203fedb4bb | 2024-02-27 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE |
| Bendeka | BENDAMUSTINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | ace9a43b-f9bd-4896-abfe-0ef4fec67ddf | 2024-01-19 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE |
| BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | Eugia US LLC | dbe34bc1-06b2-493f-8859-e8b143357aa8 | 2023-07-05 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE BENDAMUSTINE HYDROCHLORIDE |
| TREANDA | BENDAMUSTINE HYDROCHLORIDE | Cephalon, LLC | 39d53698-57fa-7c99-fc5b-f52a55684826 | 2022-10-27 | Warnings, Adverse reactions | BENDAMUSTINE HYDROCHLORIDE |