NDA 019564

ABBOTT

FDA Drug Application

Application #019564

Application Sponsors

NDA 019564

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	0	AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
002	INJECTABLE;INJECTION	3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML	0	AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
003	INJECTABLE;INJECTION	4.25%;10GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML	0	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
004	INJECTABLE;INJECTION	4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML	0	AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1986-12-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	1987-12-28

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19564
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"3.5%;5GM\/100ML;30MG\/100ML;97MG\/100ML;120MG\/100ML;49.3MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 3.5% W\/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"3.5%;25GM\/100ML;51MG\/100ML;22.4MG\/100ML;261MG\/100ML;205MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","strength":"4.25%;10GM\/100ML;30MG\/100ML;97MG\/100ML;120MG\/100ML;49.3MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 4.25% W\/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","strength":"4.25%;25GM\/100ML;51MG\/100ML;22.4MG\/100ML;261MG\/100ML;205MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"3.5%;5GM\/100ML;30MG\/100ML;97MG\/100ML;120MG\/100ML;49.3MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 3.5% W\/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"3.5%;25GM\/100ML;51MG\/100ML;22.4MG\/100ML;261MG\/100ML;205MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE","actionType":"4.25%;10GM\/100ML;30MG\/100ML;97MG\/100ML;120MG\/100ML;49.3MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 4.25% W\/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE","actionType":"4.25%;25GM\/100ML;51MG\/100ML;22.4MG\/100ML;261MG\/100ML;205MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)