Home Applications 210089 Application 210089
Type BLA
Sponsor CIS BIO INTL Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 210089 Pulmotech 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 PULMOTECH MAA TECHNETIUM TC99M ALBUMIN AGGREGATED INJECTABLE;INJECTION 2MG Yes 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 Pulmotech MAA KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED Curium US LLC a8b7adf0-2c6b-4acd-96d3-a099306951a0 2025-10-13 Warnings, Adverse reactions Exact identifier application number: BLA210089 ndc (product): 69945-139
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 69945-139 Pulmotech MAA kit for the preparation of technetium Tc 99m albumin aggregated Curium US LLC BLA Current 69945-139 Pulmotech MAA kit for the preparation of technetium Tc 99m albumin aggregated Curium US LLC BLA Current 69945-139 Pulmotech MAA kit for the preparation of technetium Tc 99m albumin aggregated Curium US LLC BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 75310 SUPPL 2023-08-29 75301 SUPPL 2023-08-28 64888 ORIG 2020-10-13 62282 ORIG 2020-03-24 62270 APPL 2020-03-24 62220 ORIG 2020-03-23