FDA.reportPublic FDA data

Application 065224

Type
ANDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONE IN PLASTIC CONTAINERCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 20MG BASE/MLNoYes
002CEFTRIAXONE IN PLASTIC CONTAINERCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 40MG BASE/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-5002CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5002CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5002CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5002CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5002CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5003CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5003CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5003CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5003CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent
0338-5003CeftriaxoneCeftriaxone SodiumBaxter Healthcare CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23739ORIG2008-09-19