APPLICATION
ANDA073654
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2015-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 50MG · TABLET · ORAL
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 100MG · TABLET · ORAL
METOPROLOL TARTRATEDiscontinued
METOPROLOL TARTRATE 25MG · TABLET · ORAL
Approval history
2015-06-22Labeling · Supplement 34 · standardAP
2015-06-22Labeling · Supplement 33 · standardAP
2011-09-20Labeling · Supplement 32AP
2009-07-15Labeling · Supplement 30AP
2007-05-09Labeling · Supplement 28AP
2003-01-06Manufacturing (CMC) · Supplement 18AP
2002-09-16Manufacturing (CMC) · Supplement 16AP
2002-08-23Manufacturing (CMC) · Supplement 17AP
2002-03-14Manufacturing (CMC) · Supplement 15AP
2001-03-23Manufacturing (CMC) · Supplement 14AP
2001-02-12Manufacturing (CMC) · Supplement 13AP
2000-05-16Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 12AP
1999-10-15Labeling · Supplement 10AP
1999-03-22Manufacturing (CMC) · Supplement 9AP
1998-08-18Manufacturing (CMC) · Supplement 8AP
1998-08-18Manufacturing (CMC) · Supplement 6AP
1998-08-18Manufacturing (CMC) · Supplement 7AP
1998-08-18Manufacturing (CMC) · Supplement 5AP
1997-12-05Manufacturing (CMC) · Supplement 4AP
1997-02-24Manufacturing (CMC) · Supplement 3AP
1995-09-15Manufacturing (CMC) · Supplement 2AP
1995-06-22Manufacturing (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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