Toprol-Xl

Lowers the risk of cardiovascular mortality and heart failure hospitalizations. NDA 19962, held by Melinta Therap. Metoprolol Succinate.

As of Nov 13, 2026, NDA 19962 (Toprol-Xl), held by Melinta Therap, was first approved by FDA on Jan 10, 1992, with 39 approved supplements and 0 published complete response letters.

First approved: Jan 10, 1992
Review: Standard
Supplements approved: 39
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TOPROL-XL, metoprolol succinate, is 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. Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure 1.1 Hypertension TOPROL-XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 40 submissions below


Jul 18, 2007	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Feb 15, 2005	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 5, 2001	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jan 10, 1992	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

4 strengths and forms


Toprol-XlEQ 50MG TARTRATE · tablet, extended release;oral	Metoprolol Succinate	RxReference drug
Toprol-XlEQ 100MG TARTRATE · tablet, extended release;oral	Metoprolol Succinate	RxReference drug
Toprol-XlEQ 200MG TARTRATE · tablet, extended release;oral	Metoprolol Succinate	RxReference drug
Toprol-XlEQ 25MG TARTRATE · tablet, extended release;oral	Metoprolol Succinate	RxReference drug

All 40 submissions, including labeling and manufacturing supplements


Mar 10, 2023	Supplement 52Labeling · Standard review	Approved	Letter Label
Mar 10, 2023	Supplement 50Labeling · Standard review	Approved	Letter Label
Jun 1, 2022	Supplement 49Labeling · Standard review	Approved	Label Letter
Jan 12, 2022	Supplement 48Labeling · Standard review	Approved	Letter Label
May 12, 2014	Supplement 45Manufacturing · Standard review	Approved	None posted
May 6, 2014	Supplement 44Labeling · Standard review	Approved	Label Letter
Oct 31, 2012	Supplement 43Labeling	Approved	Letter Label
Mar 19, 2010	Supplement 41Labeling · Standard review	Approved	Label Letter
Jan 19, 2010	Supplement 42Labeling · Standard review	Approved	Letter Label
Feb 12, 2009	Supplement 38Labeling · Standard review	Approved	Letter Label
Feb 15, 2008	Supplement 36Manufacturing	Approved	Label Letter
Jul 18, 2007	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric Written Request
Mar 14, 2007	Supplement 34Labeling · Standard review	Approved	Letter
Jul 27, 2006	Supplement 32Manufacturing	Approved	Letter Label
May 4, 2006	Supplement 31Labeling · Standard review	Approved	Letter
Apr 5, 2005	Supplement 28Labeling · Standard review	Approved	Letter
Feb 15, 2005	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2003	Supplement 24Labeling · Standard review	Approved	Letter
Mar 5, 2002	Supplement 22Labeling · Standard review	Approved	Review Letter
Oct 25, 2001	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 26, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Aug 22, 2001	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 12, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 5, 2001	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 2, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 22, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 13, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 28, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 5, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 14, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Mar 12, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Mar 11, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 13, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 7, 1995	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 27, 1994	Supplement 4Labeling · Standard review	Approved	Review
Mar 4, 1994	Supplement 3Manufacturing · Standard review	Approved	Review
Jun 24, 1992	Supplement 2Labeling	Approved	Review
Feb 27, 1992	Supplement 1Labeling	Approved	Review
Jan 10, 1992	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19962
Drugs@FDA: Overview at FDA
Company: Melinta Therapeutics

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