APPLICATION
ANDA078243
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2025-09-09
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
2025-09-09Labeling · Supplement 45 · standardAP
2024-07-08Labeling · Supplement 28 · standardAP
2024-07-08Labeling · Supplement 24 · standardAP
2024-07-08Labeling · Supplement 22 · standardAP
2024-07-08Labeling · Supplement 37 · standardAP
2015-06-10Labeling · Supplement 19 · standardAP
2015-06-10Manufacturing (CMC) · Supplement 3AP
2014-09-21Labeling · Supplement 16 · standardAP
2014-09-21Labeling · Supplement 14 · standardAP
2013-03-19Labeling · Supplement 12 · standardAP
2012-12-19Labeling · Supplement 7AP
2012-07-20Manufacturing (CMC) · Supplement 9AP
2012-01-03Labeling · Supplement 6AP
2011-03-22Labeling · Supplement 4AP
2010-10-22Labeling · 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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