General MedicationsINJECTIONStandard
NGENLA
SOMATROGON-GHLA
Standard Dose
60MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview NGENLA is listed in Drugs@FDA under application 761184 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SOMATROGON-GHLA Form and strength INJECTABLE;INJECTION - 60MG Sponsor PFIZER IRELAND PHARMACEUTICALS Submission history Latest submission status date: 2025-07-09 00:00:00.
Structured Monograph
Clinical summary
Approval overview NGENLA is listed in Drugs@FDA under application 761184 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOMATROGON-GHLA Form and strength INJECTABLE;INJECTION - 60MG Sponsor PFIZER IRELAND PHARMACEUTICALS Submission history Latest submission status date: 2025-07-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.