APPLICATION
ANDA202230
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-30
LATEST ACTION
2023-06-07
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
2023-06-07Labeling · Supplement 20 · standardAP
2023-02-28Labeling · Supplement 19 · standardAP
2019-05-21Labeling · Supplement 10 · standardAP
2016-06-09Labeling · Supplement 6 · standardAP
2015-11-12Labeling · Supplement 5 · standardAP
2014-11-04Labeling · Supplement 3 · standardAP
2013-01-28Labeling · Supplement 1 · standardAP
2012-05-30UNKNOWN · OriginalAP
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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