← FDA Drug Approvals (Drugs@FDA)

ROLVEDON

BLA · Biologics License Application · Sponsor: SPECTRUM PHARMS · Approved 2022-09-09

Drug application

FDA Application #

BLA761148

Application type

Biologics License Application

Brand name

ROLVEDON

Generic name

EFLAPEGRASTIM-XNST

Active ingredients

EFLAPEGRASTIM-XNST

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

SPECTRUM PHARMS

Manufacturer

Spectrum Pharmaceuticals, Inc.

First approval

2022-09-09

Source

Authoritative

Drugs@FDA application overview

Machine

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