← FDA DRUG APPROVALS

FDA ANDA · ANDA091629

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA091629
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2025-09-30
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

2025-09-30Labeling · Supplement 41 · standardAP
2023-09-11Labeling · Supplement 37 · standardAP
2022-07-13Labeling · Supplement 29 · standardAP
2020-03-03Labeling · Supplement 28 · standardAP
2019-06-24Labeling · Supplement 20 · standardAP
2019-04-04Manufacturing (CMC) · Supplement 19AP
2017-02-21Labeling · Supplement 15 · standardAP
2015-07-15Labeling · Supplement 4AP
2015-05-18Labeling · Supplement 12 · standardAP
2015-05-18Labeling · Supplement 13 · standardAP
2013-05-28Labeling · Supplement 11 · standardAP
2013-01-28Labeling · Supplement 7 · standardAP
2013-01-28Labeling · Supplement 5 · standardAP
2011-10-26Labeling · Supplement 1AP
2010-10-06OriginalAP
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 →