Application 020343
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | INJECTABLE;INJECTION | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | |
| N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | |
| N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | |
| N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020343-001 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020343-002 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020343-003 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020343-004 | PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1994-08-09 | 2680178bc6a6… |
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 | Mullan Pharmaceutical Inc. | 07dddead-22ed-004c-e063-6294a90a76fc | 2026-07-27 | Warnings, Adverse reactions | MILRINONE LACTATE |
| 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 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.