Home Applications 761051 Application 761051
Type BLA
Sponsor KYOWA KIRIN Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761051 Poteligeo mogamulizumab-kpkc 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POTELIGEO MOGAMULIZUMAB-KPKC INJECTABLE;INJECTION 20MG/5ML Yes 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current 42747-761 POTELIGEO mogamulizumab-kpkc Kyowa Kirin, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85137 SUPPL 2026-02-24 85100 SUPPL 2026-02-23 80917 SUPPL 2025-02-04 80911 SUPPL 2025-02-04 70674 SUPPL 2022-03-31 70668 SUPPL 2022-03-31 68070 SUPPL 2021-07-13 68040 SUPPL 2021-07-12 55394 ORIG 2018-09-07 55133 ORIG 2018-08-08 55132 ORIG 2018-08-08