APPLICATION
ANDA078232
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2026-06-08
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
2026-06-08Labeling · Supplement 44 · standardAP
2022-08-29Labeling · Supplement 39 · standardAP
2020-09-30Labeling · Supplement 30 · standardAP
2016-11-16Manufacturing (CMC) · Supplement 26 · unknownAP
2016-06-09Labeling · Supplement 25 · standardAP
2015-04-15Labeling · Supplement 2AP
2015-04-15Labeling · Supplement 23 · standardAP
2014-09-19Labeling · Supplement 22 · standardAP
2014-03-26Labeling · Supplement 18 · standardAP
2013-01-28Labeling · Supplement 16 · standardAP
2012-12-19Labeling · Supplement 5AP
2012-12-19Labeling · Supplement 8AP
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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