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FDA ANDA · ANDA201170
LOSARTAN POTASSIUM TABLETS, 25 MG
losartan potassium
Sponsor: JUBILANT CADISTA
APPLICATION
ANDA201170
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-18
LATEST ACTION
2019-07-05
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
2019-07-05Labeling · Supplement 10 · standardAP
2018-08-28Manufacturing (CMC) · Supplement 9 · unknownAP
2016-06-10Labeling · Supplement 6 · standardAP
2015-04-10Labeling · Supplement 5 · standardAP
2015-04-10Labeling · Supplement 3 · standardAP
2015-04-10Labeling · Supplement 1 · standardAP
2015-03-31Manufacturing (CMC) · Supplement 2 · unknownAP
2012-09-18Not Applicable · 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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