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FDA ANDA · ANDA201845
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: JUBILANT CADISTA
APPLICATION
ANDA201845
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-18
LATEST ACTION
2024-04-30
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
2024-04-30Labeling · Supplement 20 · standardAP
2022-07-14Labeling · Supplement 15 · standardAP
2020-03-13Labeling · Supplement 12 · standardAP
2020-03-13Labeling · Supplement 10 · standardAP
2017-09-29Labeling · Supplement 6 · standardAP
2015-04-28Labeling · Supplement 2 · standardAP
2015-04-28Labeling · Supplement 5 · standardAP
2015-04-28Labeling · Supplement 3 · standardAP
2013-06-10Labeling · Supplement 1 · standardAP
2012-09-18Not Applicable · OriginalAP
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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