← FDA DRUG APPROVALS

FDA NDA · NDA019962

TOPROL XL

metoprolol succinate

Sponsor: MELINTA THERAP

APPLICATION
NDA019962
TYPE
NDA
ORIGINAL APPROVAL
1992-01-10
LATEST ACTION
2023-03-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TOPROL-XL · ReferencePrescription
METOPROLOL SUCCINATE EQ 200MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
TOPROL-XL · ReferencePrescription
METOPROLOL SUCCINATE EQ 50MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
TOPROL-XL · ReferencePrescription
METOPROLOL SUCCINATE EQ 25MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL
TOPROL-XL · ReferencePrescription
METOPROLOL SUCCINATE EQ 100MG TARTRATE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-03-10Labeling · Supplement 52 · standard — Letter ↗AP
2023-03-10Labeling · Supplement 50 · standard — Letter ↗AP
2022-06-01Labeling · Supplement 49 · standard — Letter ↗AP
2022-01-12Labeling · Supplement 48 · standard — Letter ↗AP
2014-05-12Manufacturing (CMC) · Supplement 45 · standardAP
2014-05-06Labeling · Supplement 44 · standard — Letter ↗AP
2012-10-31Labeling · Supplement 43 · unknown — Letter ↗AP
2010-03-19Labeling · Supplement 41 · standard — Label ↗AP
2010-01-19Labeling · Supplement 42 · standard — Label ↗AP
2009-02-12Labeling · Supplement 38 · standard — Letter ↗AP
2008-02-15Manufacturing (CMC) · Supplement 36 — Label ↗AP
2007-07-18Efficacy · Supplement 33 · priority — Pediatric Medical Review ↗AP
2007-03-14Labeling · Supplement 34 · standard — Letter ↗AP
2006-07-27Manufacturing (CMC) · Supplement 32 — Letter ↗AP
2006-05-04Labeling · Supplement 31 · standard — Letter ↗AP
2005-04-05Labeling · Supplement 28 · standard — Letter ↗AP
2005-02-15Efficacy · Supplement 27 · standard — Letter ↗AP
2003-01-27Labeling · Supplement 24 · standard — Letter ↗AP
2002-03-05Labeling · Supplement 22 · standard — Review ↗AP
2001-10-25Manufacturing (CMC) · Supplement 21 · standardAP
2001-09-26Manufacturing (CMC) · Supplement 18 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 20 · standardAP
2001-06-12Manufacturing (CMC) · Supplement 19 · standardAP
2001-02-05Efficacy · Supplement 13 · standard — Review ↗AP
2001-02-02Manufacturing (CMC) · Supplement 17 · standardAP
2000-11-22Manufacturing (CMC) · Supplement 16 · standardAP
2000-10-13Manufacturing (CMC) · Supplement 14 · standardAP
2000-09-28Manufacturing (CMC) · Supplement 15 · standardAP
1999-03-05Manufacturing (CMC) · Supplement 11 · standardAP
1999-01-14Manufacturing (CMC) · Supplement 10 · standardAP
1996-06-25Labeling · Supplement 9 · standardAP
1996-03-12Labeling · Supplement 7 · standardAP
1996-03-11Manufacturing (CMC) · Supplement 8 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 6 · standardAP
1995-02-07Manufacturing (CMC) · Supplement 5 · standardAP
1994-10-27Labeling · Supplement 4 · standard — Review ↗AP
1994-03-04Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1992-06-24Labeling · Supplement 2 — Review ↗AP
1992-02-27Labeling · Supplement 1 — Review ↗AP
1992-01-10Type 2 - New Active Ingredient · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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