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FDA ANDA · ANDA091617
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: ALEMBIC PHARMS LTD
APPLICATION
ANDA091617
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-17
LATEST ACTION
2025-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
Approval history
2025-12-16Labeling · Supplement 41 · standardAP
2023-07-20Labeling · Supplement 35 · standardAP
2022-01-14Labeling · Supplement 29 · standardAP
2020-02-24Labeling · Supplement 21 · standardAP
2019-07-05Labeling · Supplement 18 · standardAP
2017-02-24Labeling · Supplement 6 · standardAP
2015-07-15Labeling · Supplement 3 · standardAP
2015-07-15Labeling · Supplement 4 · standardAP
2015-07-15Labeling · Supplement 2 · standardAP
2013-03-14Labeling · Supplement 1 · standardAP
2012-02-17OriginalAP
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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