FDA.reportPublic FDA data

Application 207131

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFAZOLIN IN PLASTIC CONTAINERCEFAZOLIN SODIUMSOLUTION;INTRAVENOUSEQ 2GM BASE/100ML (EQ 20MG BASE/ML)NoNo
002CEFAZOLIN IN PLASTIC CONTAINERCEFAZOLIN SODIUMSOLUTION;INTRAVENOUSEQ 1GM BASE/50ML (EQ 20MG BASE/ML)YesYes
003CEFAZOLIN IN DEXTROSECEFAZOLIN SODIUMSOLUTION;INTRAVENOUSEQ 3GM BASE/150ML (EQ 20MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-3503CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3503CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3503CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent
0338-3508CefazolinCefazolin SodiumBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78620SUPPL 2024-06-04
78613SUPPL 2024-06-03
77385SUPPL 2024-02-02
73525SUPPL 2024-02-02
68671SUPPL2021-09-21
66115SUPPL2021-02-05
66074SUPPL2021-02-03
47279SUPPL2017-02-22
45551SUPPL2016-10-14
24525ORIG2016-04-13
23032ORIG2016-04-13
19958ORIG2015-09-09
32847ORIG2015-08-24