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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | 74a2ff9319b5… |
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.