APPLICATION
ANDA203835
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-12
LATEST ACTION
2025-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 25MG · TABLET · ORAL
LOSARTAN POTASSIUMPrescription
LOSARTAN POTASSIUM 50MG · TABLET · ORAL
Approval history
2025-12-16Labeling · Supplement 21 · standardAP
2022-07-14Labeling · Supplement 15 · standardAP
2019-04-04Labeling · Supplement 4 · standardAP
2016-06-10Labeling · 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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