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FDA ANDA · ANDA090382

LOSARTAN POTASSIUM 25 MG

losartan potassium

Sponsor: STRIDES PHARMA

APPLICATION
ANDA090382
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2026-06-08
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

2026-06-08Labeling · Supplement 38 · standardAP
2021-12-03Labeling · Supplement 16 · standardAP
2021-12-03Labeling · Supplement 27 · standardAP
2016-05-10Labeling · Supplement 12 · standardAP
2015-11-20Labeling · Supplement 11 · standardAP
2013-05-28Labeling · Supplement 9 · standardAP
2012-12-19Labeling · Supplement 3AP
2012-12-19Labeling · Supplement 8 · standardAP
2010-11-16Labeling · Supplement 1AP
2010-10-06OriginalAP
VIEW ON DRUGS@FDA ↗

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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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