Application 204455

Type
ANDA
Sponsor
SPECTRON MRC LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONIA N 13AMMONIA N-13INJECTABLE;INTRAVENOUS30mCi-300mCi/8ML (3.75-37.5mCi/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13108-311Ammonia N 13Ammonia N 13Spectron mrc, LLCANDACurrent
13108-311Ammonia N 13Ammonia N 13NukeMed, Inc. dba SpectronRxANDACurrent