APPLICATION
ANDA078391
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-11
LATEST ACTION
2024-08-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG · CAPSULE · ORAL
Approval history
2024-08-22Labeling · Supplement 14 · standardAP
2008-02-11OriginalAP
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.