FDA.reportPublic FDA data

Application 204515

Type
ANDA
Sponsor
NCM USA BRONX LLC

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
24445-643Ammonia N 13AMMONIA N-13NCM USA Bronx LLCANDACurrent
24445-643Ammonia N 13AMMONIA N-13NCM USA Bronx LLCANDACurrent
24445-643Ammonia N 13AMMONIA N-13NCM USA Bronx LLCANDACurrent
24445-643Ammonia N 13AMMONIA N-13NCM USA Bronx LLCANDACurrent