← FDA DRUG APPROVALS
FDA ANDA · ANDA075672
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Sponsor: ACTAVIS ELIZABETH
APPLICATION
ANDA075672
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-25
LATEST ACTION
2002-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 10MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 2.5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
Approval history
2002-03-26Manufacturing (CMC) · Supplement 3AP
2002-03-06Manufacturing (CMC) · Supplement 2AP
2001-11-02Manufacturing (CMC) · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.