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AUGTYRO

NDA · New Drug Application · Sponsor: BRISTOL · Approved 2023-11-15

Drug application

FDA Application #

NDA218213

Application type

New Drug Application

Brand name

AUGTYRO

Generic name

REPOTRECTINIB

Active ingredients

REPOTRECTINIB

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

BRISTOL

Manufacturer

E.R. Squibb & Sons, L.L.C.

First approval

2023-11-15

Source

Authoritative

Drugs@FDA application overview

Machine

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