APPLICATION
ANDA075643
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-16
LATEST ACTION
2025-03-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 10MG · TABLET · ORAL
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 2.5MG · TABLET · ORAL
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 5MG · TABLET · ORAL
Approval history
2025-03-07Manufacturing (CMC) · Supplement 21 · unknownAP
2011-08-29Labeling · Supplement 11AP
2008-03-12Labeling · Supplement 9AP
2001-07-31Manufacturing (CMC) · Supplement 2AP
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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