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LAROTRECTINIB

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMACEUTICALS LIMITED · Approved 2026-06-10

Drug application

FDA Application #

ANDA220639

Application type

Abbreviated New Drug Application (Generic)

Brand name

LAROTRECTINIB

Generic name

Larotrectinib

Active ingredients

LAROTRECTINIB

Dosage form

CAPSULE

Route

—

Marketing status

None (Tentative Approval)

Sponsor

ALEMBIC PHARMACEUTICALS LIMITED

First approval

2026-06-10

Source

Authoritative

Drugs@FDA application overview

Machine

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