General MedicationsINTRAVENOUSStandard
KEYTRUDA
PEMBROLIZUMAB
Standard Dose
100MG/4ML (25MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview KEYTRUDA is listed in Drugs@FDA under application 125514 (BLA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient PEMBROLIZUMAB Form and strength SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML) Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2026-02-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview KEYTRUDA is listed in Drugs@FDA under application 125514 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PEMBROLIZUMAB Form and strength SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML) Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2026-02-10 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.