APPLICATION
ANDA040780
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-20
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2020-08-20Labeling · Supplement 20 · standardAP
2014-01-22Labeling · Supplement 9AP
2012-01-19Labeling · Supplement 12AP
2007-07-20OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.