← FDA DRUG APPROVALS

FDA NDA · NDA208711

EGATEN

triclabendazole

Sponsor: NOVARTIS

APPLICATION
NDA208711
TYPE
NDA
ORIGINAL APPROVAL
2019-02-13
LATEST ACTION
2022-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

EGATEN · ReferencePrescription
TRICLABENDAZOLE 250MG · TABLET · ORAL

Approval history

2022-02-17Labeling · Supplement 2 · standard — Label ↗AP
2019-02-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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