Application 076414
- Type
- ANDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 |
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 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A076414-001 | MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) | INJECTABLE / INJECTION | 2004-08-18 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Milrinone Lactate | MILRINONE LACTATE | Shandong New Time Pharmaceutical Co., Ltd. | 0fdaee3c-2144-4ca7-9868-54d251f468c0 | 2026-06-13 | Warnings, Adverse reactions | MILRINONE LACTATE |
| MILRINONE LACTATE | MILRINONE LACTATE | Hospira, Inc. | 813e8ca2-de54-4a7c-a2d2-8bd44396c341 | 2025-09-26 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Hikma Pharmaceuticals USA Inc. | 88f78780-399f-4780-be19-205739db1682 | 2025-05-08 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Caplin Steriles Limited | cbe097f8-9599-4f5b-bdf3-3f43d3e3461b | 2025-02-14 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Mullan Pharmaceutical Inc. | 07dddead-22ed-004c-e063-6294a90a76fc | 2025-01-15 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Hikma Pharmaceuticals USA Inc. | b3c936b3-5c86-4d87-9544-e94e95d0245f | 2023-11-20 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Armas Pharmaceuticals Inc. | fde1e354-4f15-4ade-9ae3-db2ba67e0431 | 2023-04-05 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Fresenius Kabi USA, LLC | ac43ba6b-635d-4129-8eea-96f3f5a4785e | 2023-03-17 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Somerset Therapeutics, LLC | ce43e850-4e80-4c5b-8811-9cb65824768c | 2022-09-23 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Meitheal Pharmaceuticals Inc. | 6c6b69f9-e229-4a93-a108-9eafdab614f0 | 2022-01-13 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate in Dextrose | MILRINONE LACTATE | Gland Pharma Limited | 838da14b-c070-4c09-b088-99e7c64d9964 | 2021-08-25 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate in Dextrose | MILRINONE LACTATE | Sagent Pharmaceuticals | bb0157d0-a414-43fa-81e0-8c92d717f1b2 | 2020-11-20 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate | MILRINONE LACTATE | Hikma Pharmaceuticals USA Inc. | bb7500f8-dbfd-4c8a-ac2e-5533609c3970 | 2018-06-01 | Warnings, Adverse reactions | MILRINONE LACTATE |
| Milrinone Lactate in Dextrose | MILRINONE LACTATE | Baxter Healthcare Corporation | 8fd0f93a-6150-4020-b7ee-4b95b520f6ce | 2018-05-30 | Warnings, Adverse reactions | MILRINONE LACTATE |