FDA.reportPublic FDA data

Application 202093

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDTABLET;ORAL650MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3720Tranexamic AcidTranexamic AcidActavis Pharma, Inc.ANDACurrent
0591-3720Tranexamic AcidTranexamic AcidActavis Pharma, Inc.ANDACurrent
0591-3720Tranexamic AcidTranexamic AcidActavis Pharma, Inc.ANDACurrent
63629-8599Tranexamic AcidTranexamic AcidBryant Ranch PrepackANDACurrent
63629-8838Tranexamic AcidTranexamic AcidBryant Ranch PrepackANDACurrent
63629-8838Tranexamic AcidTranexamic AcidBryant Ranch PrepackANDACurrent
68084-929Tranexamic AcidTranexamic AcidAmerican Health PackagingANDACurrent
68084-929Tranexamic AcidTranexamic AcidAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45793ORIG2016-11-02
32173ORIG2012-12-28
9957ORIG2012-05-24