← FDA DRUG APPROVALS

FDA ANDA · ANDA203018

HYDROCHLOROTHIAZIDE

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA203018
TYPE
ANDA
ORIGINAL APPROVAL
2014-07-23
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 7 · standardAP
2014-07-23UNKNOWN · OriginalAP
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 →