General MedicationsINJECTIONStandard
WINREVAIR
SOTATERCEPT-CSRK
Standard Dose
45MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview WINREVAIR is listed in Drugs@FDA under application 761363 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SOTATERCEPT-CSRK Form and strength INJECTABLE;INJECTION - 45MG Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2026-03-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview WINREVAIR is listed in Drugs@FDA under application 761363 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOTATERCEPT-CSRK Form and strength INJECTABLE;INJECTION - 45MG Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2026-03-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.