FDA.reportPublic FDA data

Application 212347

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION150MG/100ML;450MG/100MLNoNo
002POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION300MG/100ML;900MG/100MLNoNo
003POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION150MG/100ML;900MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-683Potassium Chloride in Sodium ChlorideSodium Chloride and Potassium ChlorideFresenius Kabi USA, LLCANDACurrent
63323-686Potassium Chloride in Sodium ChlorideSodium Chloride and Potassium ChlorideFresenius Kabi USA, LLCANDACurrent
63323-688Potassium Chloride in Sodium ChlorideSodium Chloride and Potassium ChlorideFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65124ORIG2020-11-02
65104ORIG2020-10-30