NDA 019713

ABBOTT

FDA Drug Application

Application #019713

Application Sponsors

NDA 019713

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	INJECTABLE;INJECTION	4.25%;10GM/100ML	0	AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE
002	INJECTABLE;INJECTION	3.5%;5GM/100ML	0	AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE
003	INJECTABLE;INJECTION	5%;25GM/100ML	0	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE
004	INJECTABLE;INJECTION	4.25%;20GM/100ML	0	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE
005	INJECTABLE;INJECTION	4.25%;25GM/100ML	0	AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE
006	INJECTABLE;INJECTION	3.5%;25GM/100ML	0	AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER	AMINO ACIDS; DEXTROSE

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19713
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"3.5%;25GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"3.5%;5GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"4.25%;10GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"4.25%;20GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"4.25%;25GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"5%;25GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"3.5%;25GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"3.5%;5GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"4.25%;10GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"4.25%;20GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"4.25%;25GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"5%;25GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)