METOPROLOL TARTRATE
Details
- Status
- Prescription
- First Approved
- 1993-12-21
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
METOPROLOL TARTRATE Approval History
What METOPROLOL TARTRATE Treats
27 FDA approvalsOriginally approved for its first indication in 1993 . Covers 27 distinct patient populations.
- Other (27)
Other
(27 approvals)- • Approved indication (Dec 1993)
- • Approved indication (Jan 1994)
- • Approved indication (Mar 1994)
- • Approved indication (May 1994)
- • Approved indication (Sep 1994)
- • Approved indication (Jan 1995)
- • Approved indication (Apr 1995)
- • Approved indication (Dec 1996)
- • Approved indication (Jul 1998)Letter
- • Approved indication (Jul 2003)
- • Approved indication (Jan 2004)
- • Approved indication (Jan 2004)
- • Approved indication (May 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Oct 2007)
- • Approved indication (Apr 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Sep 2009)
- • Approved indication (Apr 2010)
- • Approved indication (Oct 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Apr 2013)
- • Approved indication (May 2013)
- • Approved indication (Aug 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Feb 2020)
- • Approved indication (Apr 2023)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METOPROLOL TARTRATE FDA Label Details
ProIndications & Usage
Metoprolol tartrate tablets are a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Angina Pectoris. Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. 1.1 Hypertension Metoprolol tartrate tablets are indicated for the treatment of hyperte...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.