FDA.reportPublic FDA data

Application 090577

Type
ANDA
Sponsor
ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 250MG BASE/VIAL;250MG/VIALNoYes
002IMIPENEM AND CILASTATINCILASTATIN SODIUM; IMIPENEMPOWDER;INTRAVENOUSEQ 500MG BASE/VIAL;500MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-322Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent
63323-349Imipenem and CilastatinImipenem and Cilastatin SodiumFresenius Kabi USA, LLCANDACurrent