APPLICATION
ANDA203030
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-14
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 25MG · TABLET · ORAL
Approval history
2025-08-18Labeling · Supplement 10 · standardAP
2022-10-03Labeling · Supplement 7 · standardAP
2019-05-07Labeling · Supplement 4 · standardAP
2016-05-10Labeling · Supplement 1 · standardAP
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.
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