Home Applications 761369 Application 761369
Type BLA
Sponsor PFIZER INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761369 Hympavzi marstacimab-hncq 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYMPAVZI MARSTACIMAB-HNCQ INJECTABLE;SUBCUTANEOUS 300MG 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 HYMPAVZI MARSTACIMAB-HNCQ Pfizer Laboratories Div Pfizer Inc a2cc631e-13a6-40c2-acf9-065ccedfb90a 2026-06-22 Warnings, Adverse reactions Exact identifier application number: BLA761369
Documents# Document, Submission type, Date table Document Submission type Date 84434 SUPPL 2025-12-17 83378 SUPPL 2025-09-18 83363 SUPPL 2025-09-17 80192 ORIG 2024-11-12 79912 ORIG 2024-10-18 79908 ORIG 2024-10-15