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 2026-08-01
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# 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 · 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