APPLICATION
ANDA074217
TYPE
ANDA
ORIGINAL APPROVAL
1994-05-27
LATEST ACTION
2025-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 100MG · TABLET · ORAL
Approval history
2025-09-15Labeling · Supplement 29 · standardAP
2015-08-10Labeling · Supplement 26 · standardAP
2013-03-18Labeling · Supplement 25 · standardAP
2008-05-09Labeling · Supplement 19AP
2008-04-28Labeling · Supplement 18AP
2002-11-07Manufacturing (CMC) · Supplement 8AP
2002-06-12Manufacturing (CMC) · Supplement 6AP
2002-06-12Manufacturing (CMC) · Supplement 7AP
2001-09-05Manufacturing (CMC) · Supplement 5AP
2000-10-23Manufacturing (CMC) · Supplement 4AP
2000-02-25Labeling · Supplement 3AP
1999-11-10Manufacturing (CMC) · Supplement 2AP
1994-12-20Manufacturing (CMC) · Supplement 1AP
1994-05-27OriginalAP
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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