FDA.reportPublic FDA data

Application 203783

Type
ANDA
Sponsor
BRIGHAM WOMENS 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
24450-113AMMONIA N-13AMMONIA N-13Brigham and Women's Hospital, Inc., TheANDACurrent
24450-113AMMONIA N-13AMMONIA N-13Brigham and Women's Hospital, Inc., TheANDACurrent
24450-113AMMONIA N-13AMMONIA N-13Brigham and Women's Hospital, Inc., TheANDACurrent
24450-113AMMONIA N-13AMMONIA N-13Brigham and Women's Hospital, Inc., TheNDACurrent