APPLICATION
ANDA077910
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-27
LATEST ACTION
2011-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 5MG · TABLET · ORAL
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 10MG · TABLET · ORAL
Approval history
2011-08-29Labeling · Supplement 5AP
2007-12-13Labeling · Supplement 1AP
2006-12-27OriginalAP
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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