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 2026-08-01
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# 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 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