FDA.reportPublic FDA data

Application 212494

Type
ANDA
Sponsor
TULEX PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOCAPROIC ACIDAMINOCAPROIC ACIDSYRUP;ORAL1.25GM/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52817-815Aminocaproic acidAminocaproic AcidTruPharma LLCANDACurrent
52817-815Aminocaproic acidAminocaproic AcidTruPharma LLCANDACurrent
52817-815Aminocaproic acidAminocaproic AcidTruPharma LLCANDACurrent