FDA.reportPublic FDA data

Application 022119

Type
NDA
Sponsor
FEINSTEIN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13267-456Ammonia N 13NH3N13THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCHNDACurrent
13267-456Ammonia N 13NH3N13THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCHNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42423SUPPL2012-03-02
29290SUPPL2011-01-07
38285SUPPL2011-01-06
21940ORIG2007-10-02
6937ORIG2007-08-27