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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019786-001 | LOPRESSOR | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019786-002 | LOPRESSOR | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019786-003 | LOPRESSOR | EQ 300MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N019786-004 | LOPRESSOR | EQ 400MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 1989-12-27 | a50c72e98297… |
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.