← FDA Drug Approvals (Drugs@FDA)

TRESIBA

BLA · Biologics License Application · Sponsor: NOVO · Approved 2015-09-25

Drug application

FDA Application #

BLA203314

Application type

Biologics License Application

Brand name

TRESIBA

Generic name

INSULIN DEGLUDEC

Active ingredients

INSULIN DEGLUDEC

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

NOVO

Manufacturer

Novo Nordisk

First approval

2015-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

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