General MedicationsINJECTIONStandard
SAIZEN
SOMATROPIN
Standard Dose
8.8MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SAIZEN is listed in Drugs@FDA under application 019764 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SOMATROPIN Form and strength INJECTABLE;INJECTION - 8.8MG/VIAL Sponsor EMD SERONO Submission history Latest submission status date: 2017-05-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview SAIZEN is listed in Drugs@FDA under application 019764 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOMATROPIN Form and strength INJECTABLE;INJECTION - 8.8MG/VIAL Sponsor EMD SERONO Submission history Latest submission status date: 2017-05-08 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.