Home Applications 761412 Application 761412
Type BLA
Sponsor SUNSHINE LAKE PHARMA CO LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761412 Langlara insulin glargine-aldy 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LANGLARA INSULIN GLARGINE-ALDY INJECTABLE;SUBCUTANEOUS 100UNITS/ML 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 LANGLARA INSULIN GLARGINE-ALDY Lanexa Biologics, LLC 5328761e-59d3-ca7a-e063-6394a90ae810 2026-06-07 Warnings, Adverse reactions Exact identifier application number: BLA761412
Documents# Document, Submission type, Date table Document Submission type Date 85799 ORIG 2026-05-01 85798 ORIG 2026-05-01