Application 204356

Type
ANDA
Sponsor
WI MEDCL CYCLOTRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMMONIA N 13AMMONIA N-13INJECTABLE;INTRAVENOUS3.75-260mCi/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44338-002Ammonia N 13Ammonia N-13Wisconsin Medical Cyclotron, LLCANDACurrent
44338-002Ammonia N 13Ammonia N-13Wisconsin Medical Cyclotron, LLCANDACurrent
81365-002AMMONIA N 13AMMONIA N-13Wisconsin Medical Radiopharmacy, LLCANDACurrent
81365-002AMMONIA N 13AMMONIA N-13Wisconsin Medical Radiopharmacy, LLCANDACurrent