APPLICATION
ANDA076958
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-06
LATEST ACTION
2026-05-07
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
2026-05-07Labeling · Supplement 19 · standardAP
2022-06-30Labeling · Supplement 17 · standardAP
2016-06-09Labeling · Supplement 14 · standardAP
2015-10-22Labeling · Supplement 12 · standardAP
2014-09-21Labeling · Supplement 11 · standardAP
2014-09-21Labeling · Supplement 9 · standardAP
2012-12-19Labeling · Supplement 8 · standardAP
2012-12-19Labeling · Supplement 7AP
2011-01-31Labeling · Supplement 6AP
2011-01-31Labeling · Supplement 4AP
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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