Application 204352

Type
ANDA
Sponsor
BIOMEDCL RES FDN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONIA N 13AMMONIA N-13INJECTABLE;INTRAVENOUS48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24562-004Ammonia N 13Ammonia N-13Biomedical Research Foundation of Northwest LouisianaANDACurrent
24562-004Ammonia N 13Ammonia N-13Biomedical Research Foundation of Northwest LouisianaANDACurrent