Home Applications 761399 Application 761399
Type BLA
Sponsor CELLTRION INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761399 Omlyclo omalizumab-igec 351(k) Interchangeable Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMLYCLO OMALIZUMAB-IGEC INJECTABLE;INJECTION 75MG/0.5ML No No 002 OMLYCLO OMALIZUMAB-IGEC INJECTABLE;INJECTION 150MG/ML No No 003 OMLYCLO OMALIZUMAB-IGEC INJECTABLE;INJECTION 300MG/2ML No No
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Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OMLYCLO OMALIZUMAB-IGEC CELLTRION USA, Inc. dbd8709f-1636-45d9-ba94-5a3bc5f22f84 2026-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761399
Documents# Document, Submission type, Date table Document Submission type Date 85555 ORIG 2026-03-27 84728 SUPPL 2026-01-09 84727 SUPPL 2026-01-09 81481 ORIG 2025-03-07 81479 ORIG 2025-03-07