FDA.reportPublic FDA data

Application 065306

Type
ANDA
Sponsor
ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo
002CEFAZOLIN SODIUMCEFAZOLIN SODIUMINJECTABLE;INJECTIONEQ 20GM BASE/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
25021-102Cefazolincefazolin sodiumSagent PharmaceuticalsANDACurrent
44567-708CefazolinCefazolinWG Critical Care, LLCANDACurrent
44567-708CefazolinCefazolinWG Critical Care, LLCANDACurrent
44567-708CefazolinCefazolinWG Critical Care, LLCANDACurrent
44567-708CefazolinCefazolinWG Critical Care, LLCANDACurrent
63323-238CefazolinCefazolin SodiumFresenius Kabi USA, LLCANDACurrent
63323-238CefazolinCefazolin SodiumFresenius Kabi USA, LLCANDACurrent
63323-238CefazolinCefazolin SodiumFresenius Kabi USA, LLCANDACurrent
63323-449CefazolinCefazolin SodiumFresenius Kabi USA, LLCANDACurrent
63323-449CefazolinCefazolin SodiumFresenius Kabi USA, LLCANDACurrent