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FDA Approval

EGATEN

CompanyNovartis Pharmaceuticals Corporation (DUNS: 002147023)

Effective Date

January 22, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Triclabendazole(250 mg in 1 1)

Products (1)

EGATEN

NDC Product Code

0078-0937

Application Number

NDA208711

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

February 13, 2019

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TriclabendazoleActive

Code: 4784C8E03OClass: ACTIBQuantity: 250 mg in 1 1

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYMETELLOSE (4150 MPA.S)Inactive

Code: UVP539BB9QClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

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