FDA.reportPublic FDA data

Application 213944

Type
ANDA
Sponsor
OPTIMUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOCAPROIC ACIDAMINOCAPROIC ACIDTABLET;ORAL500MGNoNo
002AMINOCAPROIC ACIDAMINOCAPROIC ACIDTABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13925-530Aminocaproic AcidAminocaproic AcidSeton Pharmaceuticals, LLCANDACurrent
13925-531Aminocaproic AcidAminocaproic AcidSeton Pharmaceuticals, LLCANDACurrent