Home Applications 017881 Application 017881
Type BLA
Sponsor DRAXIMAGE Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017881 Draximage MAA kit for the preparation of technetium Tc-99m albumin aggregated 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT INJECTABLE;INJECTION N/A 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DRAXIMAGE MAA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED Jubilant DraxImage Inc bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b 2024-02-13 Warnings, Adverse reactions Exact identifier application number: BLA017881 ndc (product): 65174-270
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65174-270 DRAXIMAGE MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Jubilant DraxImage Inc., dba Jubilant Radiopharma BLA Current 65174-270 DRAXIMAGE MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Jubilant DraxImage Inc. NDA Current 65174-270 DRAXIMAGE MAA Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Jubilant DraxImage Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 76723 SUPPL 2023-12-05 76721 SUPPL 2023-12-04 50157 SUPPL 2020-03-23 13944 SUPPL 2020-03-23 11087 SUPPL 2020-03-23 11086 SUPPL 2020-03-23 739 SUPPL 2020-03-23 738 SUPPL 2020-03-23 737 SUPPL 2020-03-23 736 SUPPL 2020-03-23