Application 018226
- Type
- NDA
- Sponsor
- VALIDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUMEX | BUMETANIDE | INJECTABLE;INJECTION | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018226-001 | BUMEX | BUMETANIDE | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 |
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| 2026-08 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018226-001 | BUMEX | 0.25MG/ML | INJECTABLE / INJECTION | RLD | 1983-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018226-001 | BUMEX | 0.25MG/ML | INJECTABLE / INJECTION | RLD | 1983-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018226-001 | BUMEX | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1983-02-28 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| bumetanide | BUMETANIDE | Zydus Pharmaceuticals (USA) Inc. | 525138cd-832a-41d0-84b0-83921b12bd2a | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| bumetanide | BUMETANIDE | Zydus Lifesciences Limited | 82eb62ca-c32b-4ff8-9f71-43219b240480 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| bumetanide | BUMETANIDE | A-S Medication Solutions | cf29e436-b630-4b03-bb9b-9267ae77dc00 | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Sandoz Inc | 05cb961d-ac33-4bcf-b04e-411e496c43c1 | 2023-06-30 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Civica, Inc. | 308c690f-c2bd-4c32-8728-42ec95425f77 | 2023-04-07 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | 7f9dccf8-37ff-454b-9d55-7f1d631c8483 | 2023-01-25 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | GLENMARK PHARMACEUTICALS INC., USA | 680563fe-5d3a-49bc-86a5-740bda2acebe | 2023-01-09 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | f6ff0d37-c67d-4b9f-8b62-5deda9783c28 | 2023-01-05 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | A-S Medication Solutions | 8bed63fb-91ec-4132-ac0a-16c4c6f58d95 | 2023-01-03 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Fresenius Kabi USA, LLC | a007f3aa-3977-4be3-a9a2-db3d458bca58 | 2022-09-19 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Novadoz Pharmaceuticals LLC | 387edfd4-be85-41cd-8a6d-14e6a022b5a9 | 2022-08-09 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Gland Pharma Limited | 4d1ed6b2-c410-4f52-9b8a-aa256c37089e | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
| Bumetanide | BUMETANIDE | Aphena Pharma Solutions - Tennessee, LLC | 7e47e7b1-d28a-4e12-882f-cf193b7f2697 | 2019-09-30 | Boxed warning, Warnings, Adverse reactions | BUMETANIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.