APPLICATION
ANDA077459
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2026-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOSARTAN POTASSIUMDiscontinued
LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUMDiscontinued
LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUMDiscontinued
LOSARTAN POTASSIUM 25MG · TABLET · ORAL
Approval history
2026-01-16Labeling · Supplement 15 · standardAP
2022-09-16Labeling · Supplement 14 · standardAP
2020-09-30Labeling · Supplement 12 · standardAP
2016-06-10Labeling · Supplement 10 · standardAP
2015-06-13Labeling · Supplement 9 · standardAP
2014-09-26Labeling · Supplement 8 · standardAP
2013-03-19Labeling · Supplement 7 · standardAP
2012-12-19Labeling · Supplement 6 · standardAP
2011-02-15Manufacturing (CMC) · Supplement 2AP
2010-11-16Labeling · 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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