FDA.reportPublic FDA data

Application 078177

Type
ANDA
Sponsor
FRESENIUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION900MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46163-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
46163-300Sodium ChlorideSodium ChlorideFresenius Medical Care de Mexico, S.A. de C.V.ANDACurrent
46163-300Sodium ChlorideSodium ChlorideFresenius Medical Care de Mexico, S.A. de C.V.ANDACurrent
46163-300Sodium ChlorideSodium ChlorideFresenius Medical Care de Mexico, S.A. de C.V.ANDACurrent
46163-300Sodium ChlorideSodium ChlorideFresenius Medical Care de Mexico, S.A. de C.V.ANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent
49230-300Sodium ChlorideSodium ChlorideFresenius Medical Care North AmericaANDACurrent