Home Applications 761097 Application 761097
Type BLA
Sponsor REGENERON PHARMACEUTICALS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761097 Libtayo cemiplimab-rwlc 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIBTAYO CEMIPLIMAB-RWLC INJECTABLE;INTRAVENOUS 350MG 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current 61755-008 LIBTAYO cemiplimab-rwlc Regeneron Pharmaceuticals, Inc. BLA Current