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FDA ANDA · ANDA091590

LOSARTAN POTASSIUM

Sponsor: MYLAN

APPLICATION
ANDA091590
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2016-05-20
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

2016-05-20Labeling · Supplement 4 · standardAP
2016-05-20Labeling · Supplement 5 · standardAP
2013-01-28Labeling · Supplement 2 · standardAP
2011-01-28Manufacturing (CMC) · Supplement 1AP
2010-10-06OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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