FDA.reportPublic FDA data

Application 062831

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo
003CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3450CefazolinCefazolinSandoz IncANDACurrent
0781-3450CefazolinCefazolinSandoz IncANDACurrent
0781-3450CefazolinCefazolinSandoz IncANDACurrent
0781-3450CefazolinCefazolinSandoz IncANDACurrent
0781-3450CefazolinCefazolinSandoz IncANDACurrent
0781-3451CefazolinCefazolinSandoz IncANDACurrent
0781-3451CefazolinCefazolinSandoz IncANDACurrent
0781-3451CefazolinCefazolinSandoz IncANDACurrent
0781-3451CefazolinCefazolinSandoz IncANDACurrent
0781-3451CefazolinCefazolinSandoz IncANDACurrent
0781-3452CefazolinCefazolinSandoz IncANDACurrent
0781-3452CefazolinCefazolinSandoz IncANDACurrent
0781-3452CefazolinCefazolinSandoz IncANDACurrent
0781-3452CefazolinCefazolinSandoz IncANDACurrent
0781-3452CefazolinCefazolinSandoz IncANDACurrent
0781-9338CefazolinCefazolinSandoz IncANDACurrent
52584-024CefazolinCefazolinGeneral Injectables & Vaccines, IncANDACurrent
55154-5439CefazolinCefazolinCardinal HealthANDACurrent