Application 215370

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATEINJECTABLE;INJECTION30MG/100ML;37MG/100ML;368MG/100ML;526MG/100ML;502MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65219-387Multiple Electrolytes pH 5.5sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chlorideFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71686ORIG2022-08-01