APPLICATION
ANDA074133
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2021-06-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2021-06-09Labeling · Supplement 36 · standardAP
2016-01-30Labeling · Supplement 22 · standardAP
2013-02-27Labeling · Supplement 21 · standardAP
2010-03-11Labeling · Supplement 18AP
2008-11-04Labeling · Supplement 17AP
2008-04-28Labeling · Supplement 16AP
2002-09-19Manufacturing (CMC) · Supplement 10AP
2002-09-19Manufacturing (CMC) · Supplement 9AP
2002-09-03Manufacturing (CMC) · Supplement 8AP
2002-09-03Manufacturing (CMC) · Supplement 7AP
2001-02-14Manufacturing (CMC) · Supplement 6AP
1995-12-22Manufacturing (CMC) · Supplement 5AP
1995-06-01Manufacturing (CMC) · Supplement 4AP
1995-06-01Manufacturing (CMC) · Supplement 2AP
1995-06-01Manufacturing (CMC) · Supplement 3AP
1995-06-01Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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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