Application 019682

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLNoNo
002AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINJECTABLE;INJECTION4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100MLNoNo
003AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDEINJECTABLE;INJECTION4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1507SUPPL2004-05-27
1506SUPPL2004-05-27
1505SUPPL2004-05-27