FDA.reportPublic FDA data

Application 208790

Type
ANDA
Sponsor
ACS DOBFAR SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERTAPENEM SODIUMERTAPENEM SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9398ertapenem sodiumertapenem sodiumHikma Pharmaceuticals USA, Inc.ANDACurrent
0409-3510ErtapenemErtapenemHospira, Inc.ANDACurrent
44567-820ertapenemertapenemWG Critical Care, LLCANDACurrent
44567-820ertapenemertapenemWG Critical Care, LLCANDACurrent
44567-820ertapenemertapenemWG Critical Care, LLCANDACurrent
44567-820ertapenem sodiumertapenem sodiumWG Critical Care, LLCANDACurrent
44567-820ertapenemertapenemWG Critical Care, LLCANDACurrent
44567-820ertapenem sodiumertapenem sodiumWG Critical Care, LLCANDACurrent
63323-823ErtapenemErtapenem SodiumFresenius Kabi USA, LLCANDACurrent
63323-823ErtapenemErtapenem SodiumFresenius Kabi USA, LLCANDACurrent
63323-823ErtapenemErtapenem SodiumFresenius Kabi USA, LLCANDACurrent
63323-823ErtapenemErtapenem SodiumFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54080ORIG2018-05-10