FDA.reportPublic FDA data

Application 071192

Type
ANDA
Sponsor
LUITPOLD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOCAPROIC ACIDAMINOCAPROIC ACIDINJECTABLE;INJECTION250MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-9120Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9120Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9120Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9120Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9191Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9191Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9191Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
0517-9191Aminocaproic AcidAminocaproic AcidAmerican Regent, Inc.ANDACurrent
72572-015Aminocaproic AcidAminocaproic AcidCivica, Inc.ANDACurrent