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FDA NDA · NDA214622

TRUSELTIQ

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APPLICATION
NDA214622
TYPE
NDA
ORIGINAL APPROVAL
2021-05-28
LATEST ACTION
2021-05-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TRUSELTIQ · ReferenceDiscontinued
INFIGRATINIB PHOSPHATE 25MG · CAPSULE · ORAL
TRUSELTIQ · ReferenceDiscontinued
INFIGRATINIB PHOSPHATE 100MG · CAPSULE · ORAL

Approval history

2021-05-28Type 1 - New Molecular Entity · Original · priorityLabelAP
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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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