Application 091374

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESMOPRESSIN ACETATEDESMOPRESSIN ACETATEINJECTABLE;INJECTION0.004MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-4310Desmopressin AcetateDesmopressin AcetateAmerican Regent, Inc.ANDACurrent