← FDA DRUG APPROVALS

FDA ANDA · ANDA078245

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Sponsor: LUPIN LTD

APPLICATION
ANDA078245
TYPE
ANDA
ORIGINAL APPROVAL
2010-05-21
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-10-24Labeling · Supplement 46 · standardAP
2023-07-31Labeling · Supplement 40 · standardAP
2022-09-14Labeling · Supplement 31 · standardAP
2022-09-14Labeling · Supplement 28 · standardAP
2022-09-14Labeling · Supplement 24 · standardAP
2017-10-25Labeling · Supplement 23 · standardAP
2015-10-28Labeling · Supplement 21 · standardAP
2015-10-28Labeling · Supplement 18 · standardAP
2015-10-28Labeling · Supplement 22 · standardAP
2013-03-05Labeling · Supplement 14 · standardAP
2013-03-05Labeling · Supplement 5AP
2011-02-03Labeling · Supplement 2AP
2010-10-06OriginalAP
2010-05-21OriginalAP
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 →