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FDA ANDA · ANDA219489

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Sponsor: UNIQUE PHARM

APPLICATION
ANDA219489
TYPE
ANDA
ORIGINAL APPROVAL
2026-03-24
LATEST ACTION
2026-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEPrescription
BISOPROLOL FUMARATE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
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

Approval history

2026-03-24UNKNOWN · Original · standardAP
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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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