Home Applications 761212 Application 761212
Type BLA
Sponsor LUPIN LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761212 Armlupeg pegfilgrastim-unne 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARMLUPEG PEGFILGRASTIM-UNNE INJECTION;SOLUTION 6MG/0.6ML 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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ARMLUPEG PEGFILGRASTIM-UNNE Lupin Pharmaceuticals, Inc. c48fe1a7-63d7-4dce-bb53-a913cb0ade83 2026-07-23 Warnings, Adverse reactions Exact identifier application number: BLA761212
Documents# Document, Submission type, Date table Document Submission type Date 85273 ORIG 2026-03-05 85272 ORIG 2026-03-05 84343 ORIG 2025-12-01