APPLICATION
ANDA075831
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-14
LATEST ACTION
2015-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BISOPROLOL FUMARATEDiscontinued
BISOPROLOL FUMARATE 10MG · TABLET · ORAL
BISOPROLOL FUMARATEDiscontinued
BISOPROLOL FUMARATE 5MG · TABLET · ORAL
Approval history
2015-06-29Labeling · Supplement 10 · standardAP
2008-06-27Labeling · Supplement 4AP
2005-12-14OriginalAP
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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