APPLICATION
ANDA219044
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-16
LATEST ACTION
2025-04-16
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
2025-04-16UNKNOWN · Original · standardAP
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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