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FDA ANDA · ANDA075644

BISOPROLOL FUMARATE

Sponsor: TEVA PHARMS

APPLICATION
ANDA075644
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-26
LATEST ACTION
2015-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2015-04-13Labeling · Supplement 26AP
2008-05-27Labeling · Supplement 24AP
2006-12-08Labeling · Supplement 23AP
2006-05-04Labeling · Supplement 22AP
2002-08-28Manufacturing (CMC) · Supplement 9AP
2002-08-28Manufacturing (CMC) · Supplement 7AP
2002-08-28Manufacturing (CMC) · Supplement 5AP
2002-08-28Manufacturing (CMC) · Supplement 3AP
2002-08-28Manufacturing (CMC) · Supplement 1AP
2002-08-28Manufacturing (CMC) · Supplement 10AP
2002-08-28Manufacturing (CMC) · Supplement 8AP
2002-08-28Manufacturing (CMC) · Supplement 6AP
2002-08-28Manufacturing (CMC) · Supplement 4AP
2002-08-28Manufacturing (CMC) · Supplement 11AP
2002-08-28Manufacturing (CMC) · Supplement 2AP
2001-06-26OriginalAP
VIEW ON DRUGS@FDA ↗

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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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