← FDA Drug Approvals (Drugs@FDA)

XULTOPHY 100/3.6

BLA · Biologics License Application · Sponsor: NOVO · Approved 2016-11-21

Drug application

FDA Application #

BLA208583

Application type

Biologics License Application

Brand name

XULTOPHY 100/3.6

Generic name

INSULIN DEGLUDEC AND LIRAGLUTIDE

Active ingredients

INSULIN DEGLUDEC; LIRAGLUTIDE

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

NOVO

Manufacturer

Novo Nordisk

First approval

2016-11-21

Source

Authoritative

Drugs@FDA application overview

Machine

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