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FDA ANDA · ANDA078385
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Sponsor: ZYDUS PHARMS USA INC
APPLICATION
ANDA078385
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-06
LATEST ACTION
2020-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, LOSARTAN POTASSIUM 50MG · TABLET · ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, LOSARTAN POTASSIUM 100MG · TABLET · ORAL
Approval history
2020-02-24Labeling · Supplement 18 · standardAP
2019-07-08Labeling · Supplement 17 · standardAP
2016-07-15Labeling · Supplement 16 · standardAP
2015-10-06Labeling · Supplement 14 · standardAP
2014-08-15Labeling · Supplement 11 · standardAP
2013-11-06Labeling · Supplement 10 · standardAP
2013-03-08Labeling · Supplement 8AP
2013-02-20Labeling · Supplement 9 · standardAP
2013-01-28Labeling · Supplement 7AP
2011-09-21Labeling · Supplement 6AP
2010-10-30Labeling · Supplement 1AP
2010-10-06OriginalAP
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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