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FDA ANDA · ANDA202079

CANDESARTAN CILEXETIL

Sponsor: APOTEX

APPLICATION
ANDA202079
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-10
LATEST ACTION
2016-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CANDESARTAN CILEXETILDiscontinued
CANDESARTAN CILEXETIL 16MG · TABLET · ORAL
CANDESARTAN CILEXETILDiscontinued
CANDESARTAN CILEXETIL 4MG · TABLET · ORAL
CANDESARTAN CILEXETILDiscontinued
CANDESARTAN CILEXETIL 32MG · TABLET · ORAL
CANDESARTAN CILEXETILDiscontinued
CANDESARTAN CILEXETIL 8MG · TABLET · ORAL

Approval history

2016-02-12Labeling · Supplement 2 · standardAP
2014-01-10Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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