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FDA ANDA · ANDA210302

CANDESARTAN CILEXETIL

Sponsor: ALEMBIC

APPLICATION
ANDA210302
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-04
LATEST ACTION
2021-03-04
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 8MG · TABLET · ORAL

Approval history

2021-03-04Labeling · Supplement 5 · standardAP
2018-12-04UNKNOWN · Original · standardAP
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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