Home PurpleBook 761183 Tzield Purple Book BLA 761183
BLA number 761183
Proprietary names Tzield
Proper names teplizumab-mzwv
Applicant Provention Bio, Inc.
Center CDER
First observed release 2022-11-01
Latest observed release 2026-08-01
Newest archive release 2026-08-01
FDA patent list No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage Present in newest release Latest Known Product Presentations# Product, Proprietary name, Proper name table Product Proprietary name Proper name License type Strength Dosage form Route Presentation Marketing Licensure Approval Patent list provided 001 Tzield teplizumab-mzwv 351(a) 2MG/2ML (1MG/ML) Injection Intravenous Single-Dose Vial Rx Licensed 2022-11-17
Published Patent List# No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events# Release, Event, Product table Release Event Product Name License type Status Applicant 2026-04-01 U 001 Tzield 351(a) Rx Provention Bio, Inc. 2022-11-01 N 001 Tzield 351(a) Rx Provention Bio, Inc.
Observed Product State History# Release, Product, Name table Release Product Name License type Marketing Licensure Approval 2022-11-01 001 Tzield 351(a) Rx Licensed 2022-11-17
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