Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 5%;25GM/100ML | 0 | AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1986-12-17 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1987-06-27 | |
CDER Filings
ABBOTT
cder:Array
(
[0] => Array
(
[ApplNo] => 19565
[companyName] => ABBOTT
[docInserts] => ["",""]
[products] => [{"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 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
)
)