APPLICATION
ANDA078635
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-18
LATEST ACTION
2019-08-07
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
2019-08-07Labeling · Supplement 17 · standardAP
2016-08-19Manufacturing (CMC) · Supplement 8AP
2015-05-26Labeling · Supplement 1AP
2009-08-18OriginalAP
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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