FDA.reportPublic FDA data

Application 208374

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIVALIRUDIN IN 0.9% SODIUM CHLORIDEBIVALIRUDINSOLUTION;INTRAVENOUS250MG/50ML (5MG/ML)YesYes
002BIVALIRUDIN IN 0.9% SODIUM CHLORIDEBIVALIRUDINSOLUTION;INTRAVENOUS500MG/100ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-9572Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9572Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9572Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9572Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9576Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9576Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9576Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent
0338-9576Bivalirudin in 0.9% Sodium ChlorideBivalirudin in 0.9% Sodium Chloride InjectionBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65891SUPPL2021-01-12
65872SUPPL2021-01-08
52671ORIG2018-02-20
50918ORIG2017-12-27
50865ORIG2017-12-26