← FDA DRUG APPROVALS

FDA NDA · NDA017963

LOPRESSOR

metoprolol tartrate

Sponsor: VALIDUS PHARMS

APPLICATION
NDA017963
TYPE
NDA
ORIGINAL APPROVAL
1978-08-07
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LOPRESSOR · ReferencePrescription
METOPROLOL TARTRATE 50MG · TABLET · ORAL
LOPRESSOR · ReferencePrescription
METOPROLOL TARTRATE 100MG · TABLET · ORAL

Approval history

2023-12-22Labeling · Supplement 76 · standard — Letter ↗AP
2023-07-05Labeling · Supplement 74 · standard — Label ↗AP
2016-03-21Manufacturing (CMC) · Supplement 71 · priorityAP
2014-10-30Manufacturing (CMC) · Supplement 70 · priorityAP
2014-10-30Manufacturing (CMC) · Supplement 69 · priorityAP
2013-03-14Labeling · Supplement 68 · unknown — Label ↗AP
2012-12-21Labeling · Supplement 67 · unknown — Letter ↗AP
2011-03-15Labeling · Supplement 64 · unknown — Label ↗AP
2009-11-20Labeling · Supplement 63 · standard — Letter ↗AP
2008-07-24Labeling · Supplement 62 · standard — Letter ↗AP
2008-01-08Labeling · Supplement 61 · standard — Letter ↗AP
2006-09-05Labeling · Supplement 59 · standard — Letter ↗AP
2003-09-12Labeling · Supplement 58 · standard — Letter ↗AP
2002-06-14Manufacturing (CMC) · Supplement 57 · priorityAP
2002-04-29Manufacturing (CMC) · Supplement 56 · priorityAP
2001-07-30Manufacturing (CMC) · Supplement 55 · priorityAP
2000-05-10Manufacturing (CMC) · Supplement 54 · priorityAP
1999-04-28Manufacturing (CMC) · Supplement 53 · priorityAP
1999-03-16Labeling · Supplement 51 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 52 · priorityAP
1995-11-02Manufacturing (CMC) · Supplement 50 · priorityAP
1995-02-03Manufacturing (CMC) · Supplement 49 · priorityAP
1991-01-30Manufacturing (CMC) · Supplement 47 · priorityAP
1990-06-14Labeling · Supplement 46AP
1989-10-26Manufacturing (CMC) · Supplement 44 · priorityAP
1989-01-03Manufacturing (CMC) · Supplement 43 · priorityAP
1988-05-31Manufacturing (CMC) · Supplement 42 · priorityAP
1988-02-04Manufacturing (CMC) · Supplement 41 · priorityAP
1986-06-27Efficacy · Supplement 34AP
1985-11-20Manufacturing (CMC) · Supplement 39 · priorityAP
1985-10-16Manufacturing (CMC) · Supplement 38 · priorityAP
1985-07-30Manufacturing (CMC) · Supplement 37 · priorityAP
1985-01-03Manufacturing (CMC) · Supplement 36 · priorityAP
1984-12-14Manufacturing (CMC) · Supplement 30 · priorityAP
1984-06-28Manufacturing (CMC) · Supplement 33 · priorityAP
1984-03-30Efficacy · Supplement 24AP
1984-02-28Manufacturing (CMC) · Supplement 31 · priorityAP
1983-05-17Manufacturing (CMC) · Supplement 27 · priorityAP
1983-04-12Efficacy · Supplement 28AP
1982-10-14Manufacturing (CMC) · Supplement 25 · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →