Home Applications 761046 Application 761046
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 761046 Zinplava bezlotoxumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZINPLAVA BEZLOTOXUMAB INJECTABLE;INJECTION 1000ML/40ML No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3025 ZINPLAVA bezlotoxumab Merck Sharp & Dohme Corp. BLA Current 0006-3025 ZINPLAVA bezlotoxumab Merck Sharp & Dohme Corp. BLA Current 0006-3025 ZINPLAVA bezlotoxumab Merck Sharp & Dohme LLC BLA Current 0006-3025 ZINPLAVA bezlotoxumab Merck Sharp & Dohme Corp. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 74398 SUPPL 2023-05-30 74397 SUPPL 2023-05-30 46110 ORIG 2016-12-09 46104 ORIG 2016-12-09 45683 ORIG 2016-10-28 45639 ORIG 2016-10-25