Application 202586

Type
ANDA
Sponsor
BWXT ITG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDIUM IN 111 OXYQUINOLINEINDIUM IN-111 OXYQUINOLINEINJECTABLE;INJECTION1mCi/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72536-0920Indium In 111 OxyquinolineIndium In-111 OxyquinolineBWXT ITG Canada, Inc.ANDACurrent
72536-0920Indium In 111 OxyquinolineIndium In-111 OxyquinolineBWXT Medical Ltd.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55229ORIG2018-08-20