Fulphila

Biocon Biologics Inc.🇺🇸 United States

FDA Page

Effective Date: Jan 30, 2026
Approval ID: 9bfc4d3e-6120-7fec-f1d6-0b3743752034
Products: 1 registered
Version: 11

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for FULPHILA. FULPHILA (pegfilgrastim-jmdb) injection, for subcutaneous use Initial U.S. Approval: 2018 FULPHILA (pegfilgrastim-jmdb) is biosimilar* to NEULASTA (pegfilgrastim). (1)

Quick Stats

Total Products1

Labelers2

Label Sections17

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.