APPLICATION
ANDA090428
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
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 36 · standardAP
2021-12-17Labeling · Supplement 28 · standardAP
2021-12-17Labeling · Supplement 14 · standardAP
2016-06-10Labeling · Supplement 9 · standardAP
2015-10-26Labeling · Supplement 8 · standardAP
2014-09-25Labeling · Supplement 7 · standardAP
2013-06-10Labeling · Supplement 6 · standardAP
2012-12-21Labeling · Supplement 5 · standardAP
2012-12-21Labeling · Supplement 4AP
2011-03-30Labeling · Supplement 1AP
2010-10-06OriginalAP
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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