FDA.reportPublic FDA data

Application 203521

Type
ANDA
Sponsor
EMCURE PHARMS 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
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-166Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.ANDACurrent
23155-524Tranexamic AcidTranexamic AcidHeritage Pharmaceuticals Inc.ANDACurrent
70860-407Tranexamic Acidtranexamic acidAthenex Pharmaceutical Division, LLC.ANDACurrent