Application 018704
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPRESSOR | METOPROLOL TARTRATE | INJECTABLE;INJECTION | 1MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018704-001 | LOPRESSOR | METOPROLOL TARTRATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 |
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| 2026-08 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N018704-001 | LOPRESSOR | 1MG/ML | INJECTABLE / INJECTION | RLD | 1984-03-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 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 |
|---|---|---|---|---|---|---|
| Metoprolol Tartrate | METOPROLOL TARTRATE | A-S Medication Solutions | f4e88ecc-2d9b-4bad-97dd-77b1cbb75eb0 | 2024-10-03 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Proficient Rx LP | 5a4969d2-d569-4d2b-b698-092f07bd055a | 2024-10-01 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | TRUPHARMA LLC | 92ab5942-823d-43aa-8e7a-56844ab8946f | 2024-09-18 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Bryant Ranch Prepack | 6c7fa479-bd5f-43df-b0ab-8d8a5fd87e13 | 2024-08-27 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | A-S Medication Solutions | 70c2fada-d604-4d0c-9b3c-1f21737a77d7 | 2024-07-23 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | a2669da1-b712-5fd5-e053-2a95a90a52f3 | 2024-06-20 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | 8cce6c9a-2457-18cd-e053-2995a90a3af2 | 2024-06-18 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | 8cf0a64b-1f97-29a2-e053-2a95a90a0afd | 2024-06-18 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | 813d0b50-26d6-f732-e053-2991aa0ae24a | 2024-06-14 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | 81f6854e-72fa-83b9-e053-2a91aa0afe01 | 2024-06-14 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals,Inc. | 87ef9aa6-2faa-0f77-e053-2a95a90a3a26 | 2024-06-14 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol | METOPROLOL TARTRATE | Baxter Healthcare Corporation | 09566368-f91d-43a3-b683-30c844fb125a | 2024-05-13 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Rising Pharma Holdings, Inc. | 30b2b576-4939-4903-be59-dbd1624a5eb6 | 2024-04-05 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Golden State Medical Supply, Inc. | bec7ccad-00ad-4a3b-e053-2995a90ae3d8 | 2024-03-18 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | HF Acquisition Co LLC, DBA HealthFirst | 99b22be0-d2b4-2449-e053-2995a90a6c28 | 2024-02-22 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Aurobindo Pharma Limited | ac4ac150-d3e6-4bd1-8a4a-7d63fade3e49 | 2024-02-13 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Aurobindo Pharma Limited | 2b705cb6-cb75-4c2a-907a-4bd45d18bc2c | 2024-02-13 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Mylan Pharmaceuticals Inc. | 809c6386-0039-42ff-a03e-e42733e229b8 | 2024-01-31 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Lopressor | METOPROLOL TARTRATE | Validus Pharmaceuticals LLC | 0283bc9d-6998-493a-824a-d4c85f704111 | 2023-09-14 | Warnings, Adverse reactions | Lopressor METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | A-S Medication Solutions | 2a42adef-5af9-439e-a796-72bbd8a1748f | 2023-09-14 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64411 | SUPPL | 2020-08-25 |
| 64410 | SUPPL | 2020-08-25 |
| 64406 | SUPPL | 2020-08-25 |
| 64405 | SUPPL | 2020-08-25 |
| 33565 | SUPPL | 2013-03-15 |
| 1037 | SUPPL | 2013-03-15 |
| 33564 | SUPPL | 2013-01-02 |
| 15104 | SUPPL | 2012-12-26 |
| 15103 | SUPPL | 2010-01-06 |
| 11287 | SUPPL | 2009-11-23 |
| 1036 | SUPPL | 2008-07-30 |
| 33563 | SUPPL | 2008-07-29 |
| 1035 | SUPPL | 2008-01-09 |
| 15102 | SUPPL | 2006-09-18 |
| 1034 | SUPPL | 2003-09-25 |