← FDA DRUG APPROVALS
FDA ANDA · ANDA079106
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Sponsor: UNICHEM
APPLICATION
ANDA079106
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-28
LATEST ACTION
2024-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEPrescription
BISOPROLOL FUMARATE 10MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEPrescription
BISOPROLOL FUMARATE 2.5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEPrescription
BISOPROLOL FUMARATE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
Approval history
2024-03-01Labeling · Supplement 36 · standardAP
2022-12-01Labeling · Supplement 30 · standardAP
2011-08-29Labeling · Supplement 2AP
2010-07-28OriginalAP
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.