Home Applications 761363 Application 761363
Type BLA
Sponsor MERCK SHARP DOHME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761363 Winrevair sotatercept-csrk 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 WINREVAIR SOTATERCEPT-CSRK INJECTABLE;INJECTION 45MG No No 002 WINREVAIR SOTATERCEPT-CSRK INJECTABLE;INJECTION 60MG No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WINREVAIR SOTATERCEPT-CSRK Merck Sharp & Dohme LLC 21693ee2-cd23-4137-ac67-066bb3a4a9b7 2026-06-17 Warnings, Adverse reactions Exact identifier application number: BLA761363
Documents# Document, Submission type, Date table Document Submission type Date 85547 SUPPL 2026-03-27 85546 SUPPL 2026-03-27 84438 SUPPL 2025-12-18 84364 SUPPL 2025-12-09 83960 SUPPL 2025-10-28 77980 ORIG 2024-09-24 78413 ORIG 2024-05-07 78000 ORIG 2024-03-27