FDA.reportPublic FDA data

Application 091117

Type
ANDA
Sponsor
ASTRAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFTRIAXONE SODIUMCEFTRIAXONE SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
66794-215CeftriaxoneCeftriaxonePiramal Critical Care IncANDACurrent
70594-098CeftriaxoneCeftriaxoneXellia Pharmaceuticals USA LLCANDACurrent