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IMKELDI

NDA · New Drug Application · Sponsor: SHORLA ONCOLOGY · Approved 2024-11-22

Drug application

FDA Application #

NDA219097

Application type

New Drug Application

Brand name

IMKELDI

Generic name

IMATINIB ORAL

Active ingredients

IMATINIB MESYLATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

SHORLA ONCOLOGY

Manufacturer

Shorla Oncology Inc.,

First approval

2024-11-22

Source

Authoritative

Drugs@FDA application overview

Machine

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