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FDA ANDA · ANDA077157
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: TEVA PHARMS
APPLICATION
ANDA077157
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-06
LATEST ACTION
2022-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
Approval history
2022-07-14Labeling · Supplement 18 · standardAP
2020-03-04Labeling · Supplement 12 · standardAP
2020-03-04Labeling · Supplement 15 · standardAP
2017-02-17Labeling · Supplement 10 · standardAP
2015-02-13Labeling · Supplement 9 · standardAP
2014-11-25Labeling · Supplement 8 · standardAP
2014-11-25Labeling · Supplement 4AP
2013-03-19Labeling · Supplement 6 · standardAP
2011-10-27Labeling · Supplement 5AP
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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