← FDA DRUG APPROVALS
FDA ANDA · ANDA204901
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: PRINSTON INC
APPLICATION
ANDA204901
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-06
LATEST ACTION
2023-02-23
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 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
Approval history
2023-02-23Labeling · Supplement 7 · standardAP
2023-02-23Labeling · Supplement 5 · standardAP
2023-02-23Labeling · Supplement 3 · standardAP
2017-11-06UNKNOWN · OriginalAP
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.