← FDA DRUG APPROVALS
FDA ANDA · ANDA077948
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA077948
TYPE
ANDA
ORIGINAL APPROVAL
2010-08-19
LATEST ACTION
2023-08-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
Approval history
2023-08-10Labeling · Supplement 19 · standardAP
2022-08-04Labeling · Supplement 17 · standardAP
2022-08-04Labeling · Supplement 18 · standardAP
2022-08-04Labeling · Supplement 16 · standardAP
2017-02-16Labeling · Supplement 11 · standardAP
2015-11-10Labeling · Supplement 9 · standardAP
2015-11-10Labeling · Supplement 7 · standardAP
2013-04-26Labeling · Supplement 5 · standardAP
2013-03-19Labeling · Supplement 2AP
2010-10-06OriginalAP
2010-08-19OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.