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FDA ANDA · ANDA075579
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Sponsor: EPIC PHARMA LLC
APPLICATION
ANDA075579
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-25
LATEST ACTION
2022-03-31
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
2022-03-31Labeling · Supplement 27 · standardAP
2022-03-31Labeling · Supplement 25 · standardAP
2011-07-15Labeling · Supplement 16AP
2009-03-31Labeling · Supplement 14AP
2008-05-06Labeling · Supplement 13AP
2002-10-30Manufacturing (CMC) · Supplement 2AP
2002-10-30Manufacturing (CMC) · Supplement 3AP
2002-10-30Manufacturing (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.
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