← FDA DRUG APPROVALS
FDA ANDA · ANDA203466
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Sponsor: ZYDUS LIFESCIENCES
APPLICATION
ANDA203466
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-27
LATEST ACTION
2021-04-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 16MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEPrescription
CANDESARTAN CILEXETIL 32MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
Approval history
2021-04-30Labeling · Supplement 1 · standardAP
2017-11-27UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.