FDA.reportPublic FDA data

Application 213928

Type
ANDA
Sponsor
LEADING PHARMA LLC

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
69315-231AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent
69315-231AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent
69315-232AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent
69315-232AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent
70377-102AMINOCAPROIC ACIDAMINOCAPROIC ACIDBiocon Pharma Inc.ANDACurrent
70377-103AMINOCAPROIC ACIDAMINOCAPROIC ACIDBiocon Pharma Inc.ANDACurrent
80005-128AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent
80005-129AMINOCAPROIC ACIDAMINOCAPROIC ACIDLeading Pharma, LLCANDACurrent