← FDA DRUG APPROVALS

FDA ANDA · ANDA077885

HYDROCHLOROTHIAZIDE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA077885
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-26
LATEST ACTION
2024-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG · CAPSULE · ORAL

Approval history

2024-04-04Labeling · Supplement 4 · standardAP
2011-08-17Labeling · Supplement 1AP
2007-11-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →