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FDA ANDA · ANDA074258

METOPROLOL TARTRATE

Sponsor: APOTHECON

APPLICATION
ANDA074258
TYPE
ANDA
ORIGINAL APPROVAL
1994-01-27
LATEST ACTION
1999-08-27
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

1999-08-27Labeling · Supplement 4AP
1998-09-25Manufacturing (CMC) · Supplement 2AP
1998-09-25Manufacturing (CMC) · Supplement 3AP
1996-09-25Manufacturing (CMC) · Supplement 1AP
1994-01-27OriginalAP
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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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