APPLICATION
ANDA077424
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2022-07-13
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
2022-07-13Labeling · Supplement 15 · standardAP
2020-09-30Labeling · Supplement 14 · standardAP
2016-06-10Labeling · Supplement 10 · standardAP
2015-06-19Labeling · Supplement 8 · standardAP
2014-09-19Labeling · Supplement 6 · standardAP
2013-05-28Labeling · Supplement 5 · standardAP
2011-04-21Manufacturing (CMC) · Supplement 3AP
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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