← FDA DRUG APPROVALS

FDA ANDA · ANDA040702

HYDROCHLOROTHIAZIDE

Sponsor: LEADING

APPLICATION
ANDA040702
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-16
LATEST ACTION
2023-10-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL

Approval history

2023-10-06Labeling · Supplement 14 · standardAP
2020-08-20Labeling · Supplement 12 · standardAP
2014-10-22Manufacturing (CMC) · Supplement 6AP
2008-05-01Labeling · Supplement 3AP
2007-03-16OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →