Application 019786
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | No | No |
| 002 | LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG TARTRATE | No | No |
| 003 | LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 300MG TARTRATE | No | No |
| 004 | LOPRESSOR | METOPROLOL FUMARATE | TABLET, EXTENDED RELEASE;ORAL | EQ 400MG TARTRATE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019786-001 | LOPRESSOR | METOPROLOL FUMARATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ||
| N019786-002 | LOPRESSOR | METOPROLOL FUMARATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ||
| N019786-003 | LOPRESSOR | METOPROLOL FUMARATE | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ||
| N019786-004 | LOPRESSOR | METOPROLOL FUMARATE | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | VALIDUS PHARMACEUTICALS LLC | b5f4fed2-369c-4808-a682-8a5b8cfdbb4f | 2026-01-26 | Warnings, Adverse reactions | LOPRESSOR |
| LOPRESSOR | METOPROLOL TARTRATE | VALIDUS PHARMACEUTICALS LLC | 9f448171-9588-4a54-88b3-5d870060ce86 | 2025-05-15 | Warnings, Adverse reactions | LOPRESSOR |
| Lopressor | METOPROLOL TARTRATE | Validus Pharmaceuticals LLC | 0283bc9d-6998-493a-824a-d4c85f704111 | 2023-09-14 | Warnings, Adverse reactions | Lopressor |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.