General MedicationsSOLUTIONStandard
ARMLUPEG
PEGFILGRASTIM-UNNE
Standard Dose
6MG/0.6ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ARMLUPEG is listed in Drugs@FDA under application 761212 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PEGFILGRASTIM-UNNE Form and strength INJECTION;SOLUTION - 6MG/0.6ML Sponsor LUPIN LTD Submission history Latest submission status date: 2025-11-28 00:00:00.
Structured Monograph
Clinical summary
Approval overview ARMLUPEG is listed in Drugs@FDA under application 761212 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient PEGFILGRASTIM-UNNE Form and strength INJECTION;SOLUTION - 6MG/0.6ML Sponsor LUPIN LTD Submission history Latest submission status date: 2025-11-28 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.