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FDA ANDA · ANDA202289
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA202289
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-09
LATEST ACTION
2026-02-17
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
2026-02-17Labeling · Supplement 49 · standardAP
2023-07-28Labeling · Supplement 19 · standardAP
2023-07-28Labeling · Supplement 36 · standardAP
2023-06-07Labeling · Supplement 28 · standardAP
2020-02-21Labeling · Supplement 18 · standardAP
2019-06-24Labeling · Supplement 12 · standardAP
2017-09-29Labeling · Supplement 5 · standardAP
2014-11-04Labeling · Supplement 4 · standardAP
2013-08-27Labeling · Supplement 2 · standardAP
2012-08-09OriginalAP
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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