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| LOPRESSOR | METOPROLOL TARTRATE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 |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| 2026-08 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 84e616aacf4f… | |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| 2026-07 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | caaa826d4ba7… | |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UTC | 2026-02 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 011fe1cb6892… | |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ZIP | 2025-12 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 31067a03dcf5… | |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UTC | 2025-08 | N018704-001 | LOPRESSOR | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1984-03-30 | 6a471c1ec25d… | |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 | METOPROLOL TARTRATE | Fresenius Kabi USA, LLC | be1c686e-37a5-4a53-945b-68a6ead35134 | 2025-09-12 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Mylan Institutional Inc. | 961248d5-d53c-408d-8f8f-d31885054f96 | 2025-07-22 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Bryant Ranch Prepack | f8ac449a-d3b3-4f25-9e61-d91ef1230c72 | 2025-07-15 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Cardinal Health 107, LLC | e93d7939-31ad-4fc5-a5f3-6d565cc6d0c1 | 2025-06-25 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Bryant Ranch Prepack | 2338d4c3-ec2e-47f8-83cd-f43fed3ba7fb | 2025-06-23 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Coupler LLC | 37c9c12a-db53-1fd6-e063-6394a90afb92 | 2025-06-17 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | PD-Rx Pharmaceuticals, Inc. | 00de1f16-f979-4dbf-aa60-246ffac8d410 | 2025-06-10 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Preferred Pharmaceuticals Inc. | 4c6c75c5-9c80-44e1-bd16-b97509c9f542 | 2025-06-06 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | 7ac58d12-58bf-470d-8a5a-01a18c0c9209 | 2025-06-06 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | f56a17b5-3a2e-4f77-89e0-e4a41d802031 | 2025-06-06 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | a2add754-0bd9-4f8a-ae05-b06d35d7f423 | 2025-06-06 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | d124cdfe-8250-41c1-badb-874b1060f735 | 2025-06-06 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Coupler LLC | 3698837b-c34b-569a-e063-6394a90a167c | 2025-06-02 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | A-S Medication Solutions | 73563f90-4d1c-450b-b4d9-d39a1e39dcfd | 2025-05-29 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | 0882d731-719d-4484-b2c8-88b04a4af67f | 2025-05-28 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | b5645b28-d4b7-4671-a0c1-5e093f68f823 | 2025-05-28 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| LOPRESSOR | METOPROLOL TARTRATE | VALIDUS PHARMACEUTICALS LLC | 9f448171-9588-4a54-88b3-5d870060ce86 | 2025-05-15 | Warnings, Adverse reactions | LOPRESSOR METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | FOSUN PHARMA USA INC | 1e787808-b3e0-417a-b333-80619d15432b | 2025-04-30 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOPROLOL TARTRATE | NuCare Pharmaceuticals, Inc. | 2760fbbc-ec68-4df8-e063-6394a90a15f5 | 2025-04-03 | Warnings, Adverse reactions | METOPROLOL TARTRATE |
| Metoprolol Tartrate | METOROPROLOL TARTRATE | Hikma Pharmaceuticals USA Inc. | c7ec36bb-bc6f-42de-9974-a50ac13e9410 | 2025-03-26 | 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 |