APPLICATION
ANDA040774
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-03
LATEST ACTION
2008-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
2008-04-04Manufacturing (CMC) · Supplement 1AP
2008-04-04Manufacturing (CMC) · Supplement 2AP
2007-10-03OriginalAP
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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