← FDA DRUG APPROVALS

FDA ANDA · ANDA200180

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Sponsor: WATSON LABS

APPLICATION
ANDA200180
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-12
LATEST ACTION
2026-01-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL

Approval history

2026-01-15Labeling · Supplement 4 · standardAP
2020-05-07Labeling · Supplement 2 · standardAP
2020-05-07Labeling · Supplement 3 · standardAP
2011-01-12UNKNOWN · OriginalAP
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 →