APPLICATION
ANDA203813
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-05
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CANDESARTAN CILEXETILPrescription
CANDESARTAN CILEXETIL 16MG · TABLET · ORAL
CANDESARTAN CILEXETILPrescription
CANDESARTAN CILEXETIL 4MG · TABLET · ORAL
CANDESARTAN CILEXETILPrescription
CANDESARTAN CILEXETIL 32MG · TABLET · ORAL
CANDESARTAN CILEXETILPrescription
CANDESARTAN CILEXETIL 8MG · TABLET · ORAL
Approval history
2023-06-07Labeling · Supplement 27 · standardAP
2021-04-30Labeling · Supplement 16 · standardAP
2017-07-19Manufacturing (CMC) · Supplement 1 · unknownAP
2016-12-05UNKNOWN · 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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