← FDA Drug Approvals (Drugs@FDA)

GARZULYS

BLA · Biologics License Application · Sponsor: EMERGE BIOSCIENCE PTE. LTD. · Approved 2026-07-24

Drug application

FDA Application #

BLA761497

Application type

Biologics License Application

Brand name

GARZULYS

Generic name

INSULIN ASPART-FSAN

Active ingredients

INSULIN ASPART-FSAN

Dosage form

VIAL

Route

MULTIDOSE

Marketing status

Prescription

Sponsor

EMERGE BIOSCIENCE PTE. LTD.

Manufacturer

Meitheal Pharmaceuticals Inc.

First approval

2026-07-24

Source

Authoritative

Drugs@FDA application overview

Machine

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