APPLICATION
ANDA075768
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-25
LATEST ACTION
2024-06-25
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
2024-06-25Labeling · Supplement 27 · standardAP
2022-02-07Labeling · Supplement 22 · standardAP
2022-02-07Labeling · Supplement 20 · standardAP
2015-06-02Labeling · Supplement 16AP
2003-10-24Labeling · 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.
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