Home Applications 761364 Application 761364
Type BLA
Sponsor ACCORD BIOPHARMA INC. Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761364 Imuldosa ustekinumab-srlf 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IMULDOSA USTEKINUMAB-SRLF INJECTABLE;INTRAVENOUS 45MG/0.5ML No No 002 IMULDOSA USTEKINUMAB-SRLF INJECTABLE;INTRAVENOUS 90MG/ML No No 003 IMULDOSA USTEKINUMAB-SRLF INJECTABLE;INTRAVENOUS 130MG/26ML No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 IMULDOSA USTEKINUMAB-SRLF Accord BioPharma Inc. 2539a6cf-0fe5-1565-e063-6294a90a3618 2026-06-17 Warnings, Adverse reactions Exact identifier application number: BLA761364
Documents# Document, Submission type, Date table Document Submission type Date 84257 SUPPL 2025-11-21 84253 SUPPL 2025-11-21 84252 SUPPL 2025-11-21 82051 ORIG 2025-04-29 81630 SUPPL 2025-03-18 79874 SUPPL 2025-03-18 79876 ORIG 2024-10-15 79875 ORIG 2024-10-14