APPLICATION
ANDA091541
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-24
LATEST ACTION
2026-04-10
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
2026-04-10Labeling · Supplement 15 · standardAP
2023-08-23Labeling · Supplement 13 · standardAP
2019-05-07Labeling · Supplement 12 · standardAP
2016-06-09Labeling · Supplement 6 · standardAP
2015-10-07Labeling · Supplement 5 · standardAP
2014-11-05Labeling · Supplement 3 · standardAP
2013-06-11Labeling · Supplement 2 · standardAP
2013-01-31Labeling · Supplement 1 · standardAP
2012-09-24OriginalAP
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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