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FDA ANDA · ANDA204100
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Sponsor: MACLEODS PHARMS LTD
APPLICATION
ANDA204100
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-27
LATEST ACTION
2021-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 16MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
Approval history
2021-05-13Labeling · Supplement 18 · standardAP
2016-06-23Manufacturing (CMC) · Supplement 1AP
2016-06-23Labeling · Supplement 2 · standardAP
2015-02-27UNKNOWN · 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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