MedPath
FDA Product

CUVRIOR

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CUVRIOR

81802-001

Regulatory Information

81802-001

NDA215760

C73594

April 30, 2022

USA

These highlights do not include all the information needed to use CUVRIOR safely and effectively. See full prescribing information for CUVRIOR. CUVRIOR™ (trientine tetrahydrochloride) tablets, for oral use Initial U.S. Approval: 1985

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Orphalan SA

263303972

Active Ingredients

TRIENTINE TETRAHYDROCHLORIDE

Quantity: 300 mg in 1 1

Code: 7360URE56Q

Class Code: ACTIB

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

Active Moieties

TRIENTINE

Code: SJ76Y07H5F

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