Treats myocardial infarction. NDA 218698, held by Xtm Consulting. Metoprolol Tartrate.
As of Nov 13, 2026, NDA 218698 (Lopressor), held by Xtm Consulting, was first approved by FDA on Aug 28, 2025, with 1 approved supplement and 1 published complete response letter.
LOPRESSOR is a beta-adrenergic blocker indicated in the treatment of hemodynamically stable adult patients with myocardial infarction, to reduce the risk of cardiovascular mortality. 1.1 Myocardial Infarction
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 12, 2024 | NDA 218698Product Quality | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lopressor12.5MG · tablet;oral | Metoprolol Tartrate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2026 | Supplement 2Manufacturing | Approved | |
| Aug 28, 2025 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
