← FDA DRUG APPROVALS

FDA NDA · NDA020186

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA020186
TYPE
NDA
ORIGINAL APPROVAL
1993-03-26
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZIAC · ReferencePrescription
BISOPROLOL FUMARATE 2.5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
ZIAC · ReferencePrescription
BISOPROLOL FUMARATE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
ZIAC · ReferencePrescription
BISOPROLOL FUMARATE 10MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL

Approval history

2026-07-24Labeling · Supplement 44 · standard — Label ↗AP
2023-12-22Labeling · Supplement 42 · standard — Letter ↗AP
2021-03-02Labeling · Supplement 37 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 35 · standard — Label ↗AP
2015-07-27Manufacturing (CMC) · Supplement 32 · standardAP
2014-06-12Manufacturing (CMC) · Supplement 31 · standardAP
2013-12-12Manufacturing (CMC) · Supplement 30 · standardAP
2011-05-03Labeling · Supplement 27 · unknown — Label ↗AP
2011-05-03Labeling · Supplement 28 · unknownAP
2009-11-06Labeling · Supplement 26 · unknown — Letter ↗AP
2007-09-25Labeling · Supplement 23 · standard — Label ↗AP
2003-01-24Labeling · Supplement 15 · standard — Letter ↗AP
2000-04-04Labeling · Supplement 11 · standardAP
1999-06-22Manufacturing (CMC) · Supplement 10 · standardAP
1999-02-16Manufacturing (CMC) · Supplement 9 · standardAP
1998-04-01Labeling · Supplement 8 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 7 · standardAP
1996-10-09Manufacturing (CMC) · Supplement 6 · standardAP
1996-04-24Labeling · Supplement 5 · standardAP
1995-05-30Labeling · Supplement 4 · standard — Review ↗AP
1994-04-15Manufacturing (CMC) · Supplement 3 · standardAP
1993-11-24Manufacturing (CMC) · Supplement 2 · standardAP
1993-09-07Manufacturing (CMC) · Supplement 1 · standardAP
1993-03-26Type 4 - New Combination · 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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