← FDA DRUG APPROVALS

FDA ANDA · ANDA075474

BISOPROLOL

bisoprolol fumarate

Sponsor: TP ANDA HOLDINGS

APPLICATION
ANDA075474
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-25
LATEST ACTION
2005-01-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 10MG · TABLET · ORAL
BISOPROLOL FUMARATEPrescription
BISOPROLOL FUMARATE 5MG · TABLET · ORAL

Approval history

2005-01-04Labeling · Supplement 7AP
2002-10-25OriginalAP
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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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