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FDA ANDA · ANDA075527

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA075527
TYPE
ANDA
ORIGINAL APPROVAL
2000-09-25
LATEST ACTION
2004-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 2.5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEDiscontinued
BISOPROLOL FUMARATE 10MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL

Approval history

2004-07-21Labeling · Supplement 10AP
2002-07-25Manufacturing (CMC) · Supplement 5AP
2002-07-25Manufacturing (CMC) · Supplement 6AP
2002-01-22Manufacturing (CMC) · Supplement 3AP
2002-01-22Manufacturing (CMC) · Supplement 1AP
2002-01-22Manufacturing (CMC) · Supplement 4AP
2002-01-22Manufacturing (CMC) · Supplement 2AP
2000-09-25Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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