Home Applications 761183 Application 761183
Type BLA
Sponsor PROVENTION BIO INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761183 Tzield teplizumab-mzwv 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TZIELD TEPLIZUMAB-MZWV INJECTABLE;INJECTION 2MG/2ML(1MG/ML) 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TZIELD TEPLIZUMAB-MZWV Provention Bio, Inc. e8a39a5f-139c-4510-9777-71cbb00138fa 2026-08-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761183 ndc (product): 73650-316
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73650-316 TZIELD teplizumab-mzwv Provention Bio, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85741 SUPPL 2026-04-24 85731 SUPPL 2026-04-21 73089 ORIG 2023-01-05 72905 ORIG 2022-12-15 72666 ORIG 2022-11-22 72659 ORIG 2022-11-21