NDA 19786, held by Novartis. Metoprolol Fumarate.
As of Nov 13, 2026, NDA 19786 (Lopressor), held by Novartis, was first approved by FDA on Dec 27, 1989, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1989 | Original applicationTYPE 2/3 · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| LopressorEQ 100MG TARTRATE · tablet, extended release;oral | Metoprolol Fumarate | Discontinued |
| LopressorEQ 200MG TARTRATE · tablet, extended release;oral | Metoprolol Fumarate | Discontinued |
| LopressorEQ 300MG TARTRATE · tablet, extended release;oral | Metoprolol Fumarate | Discontinued |
| LopressorEQ 400MG TARTRATE · tablet, extended release;oral | Metoprolol Fumarate | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
