FDA.reportPublic FDA data

Application 212020

Type
NDA
Sponsor
EXELA PHARMA SCS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRANEXAMIC ACIDTRANEXAMIC ACIDSOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51754-0108TRANEXAMIC ACID IN SODIUM CHLORIDEtranexamic acidExela Pharma Sciences, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63970SUPPL2020-07-20
63946SUPPL2020-07-17
60748ORIG2019-10-31
58385ORIG2019-04-24
58361ORIG2019-04-19