FDA.reportPublic FDA data

Application 207025

Type
ANDA
Sponsor
GEN HOSP

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
76318-643Ammonia N 13ammonia n-13Massachusetts General HospitalANDACurrent
76318-643Ammonia N 13ammonia n-13Massachusetts General HospitalANDACurrent
76318-643Ammonia N 13ammonia n-13Massachusetts General HospitalANDACurrent
76318-643Ammonia N 13ammonia n-13Massachusetts General HospitalANDACurrent