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FDA NDA · NDA018704

LOPRESSOR

Sponsor: NOVARTIS

APPLICATION
NDA018704
TYPE
NDA
ORIGINAL APPROVAL
1984-03-30
LATEST ACTION
2020-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LOPRESSOR · ReferenceDiscontinued
METOPROLOL TARTRATE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2020-08-24Labeling · Supplement 27 · standard — Label ↗AP
2020-08-24Labeling · Supplement 28 · standard — Label ↗AP
2013-03-14Labeling · Supplement 26 · unknown — Letter ↗AP
2012-12-21Labeling · Supplement 25 · unknown — Letter ↗AP
2009-11-20Labeling · Supplement 23 · standard — Label ↗AP
2008-07-24Labeling · Supplement 21 · standard — Letter ↗AP
2008-01-08Labeling · Supplement 20 · standard — Letter ↗AP
2006-09-05Labeling · Supplement 18 · standard — Letter ↗AP
2003-09-12Labeling · Supplement 15 · standard — Letter ↗AP
2002-04-29Manufacturing (CMC) · Supplement 14 · priorityAP
2002-01-15Manufacturing (CMC) · Supplement 13 · priorityAP
2001-07-30Manufacturing (CMC) · Supplement 12 · priorityAP
2000-05-10Manufacturing (CMC) · Supplement 11 · priorityAP
1999-04-15Manufacturing (CMC) · Supplement 9 · priorityAP
1999-04-15Manufacturing (CMC) · Supplement 10 · priorityAP
1998-10-22Manufacturing (CMC) · Supplement 8 · priorityAP
1998-10-20Manufacturing (CMC) · Supplement 7 · priorityAP
1996-02-28Manufacturing (CMC) · Supplement 6 · priorityAP
1995-01-19Manufacturing (CMC) · Supplement 5 · priorityAP
1990-06-14Labeling · Supplement 4AP
1988-02-04Manufacturing (CMC) · Supplement 3 · priorityAP
1985-05-13Manufacturing (CMC) · Supplement 2 · priorityAP
1984-11-20Manufacturing (CMC) · Supplement 1 · priorityAP
1984-03-30Type 3 - New Dosage Form · Original · priorityAP
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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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