Application 210089

Type
BLA
Sponsor
CIS BIO INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PULMOTECH MAATECHNETIUM TC99M ALBUMIN AGGREGATEDINJECTABLE;INJECTION2MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69945-139Pulmotech MAAkit for the preparation of technetium Tc 99m albumin aggregatedCurium US LLCBLACurrent
69945-139Pulmotech MAAkit for the preparation of technetium Tc 99m albumin aggregatedCurium US LLCBLACurrent
69945-139Pulmotech MAAkit for the preparation of technetium Tc 99m albumin aggregatedCurium US LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75310SUPPL 2023-08-29
75301SUPPL 2023-08-28
64888ORIG2020-10-13
62282ORIG2020-03-24
62270APPL2020-03-24
62220ORIG2020-03-23