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FDA ANDA · ANDA215562
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Sponsor: NOVITIUM PHARMA
APPLICATION
ANDA215562
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-04
LATEST ACTION
2024-06-17
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
2024-06-17Labeling · Supplement 10 · standardAP
2021-11-04UNKNOWN · Original · standardAP
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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