FDA.reportPublic FDA data

Application 207239

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDINJECTABLE;INJECTION100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-601Tranexamic Acidtranexamic acidAlvogen Inc.ANDACurrent
47781-601Tranexamic Acidtranexamic acidAlvogen Inc.ANDACurrent
47781-601Tranexamic Acidtranexamic acidAlvogen Inc.ANDACurrent
68083-160Tranexamic acidTranexamic acidGland Pharma LimitedANDACurrent
68083-160Tranexamic acidTranexamic acidGland Pharma LimitedANDACurrent
68083-160Tranexamic acidTranexamic acidGland Pharma LimitedANDACurrent
68083-160Tranexamic acidTranexamic acidGland Pharma LimitedANDACurrent
70860-400Tranexamic Acidtranexamic acidAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-400Tranexamic Acidtranexamic acidAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-400Tranexamic Acidtranexamic acidAthenex Pharmaceutical Division, LLC.ANDACurrent
72611-760Tranexamic Acidtranexamic acidAlmaject, Inc.ANDACurrent
72611-760Tranexamic Acidtranexamic acidAlmaject, Inc.ANDACurrent