SANDOZ INC FDA Approval ANDA 090166

ANDA 090166

SANDOZ INC

FDA Drug Application

Application #090166

Documents

Letter2009-06-02

Application Sponsors

ANDA 090166SANDOZ INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10MG/ML0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP2009-05-27
LABELING; LabelingSUPPL2AP2011-03-28
LABELING; LabelingSUPPL5AP2012-11-13STANDARD
LABELING; LabelingSUPPL8AP2019-10-22STANDARD

Submissions Property Types

ORIG1Null1
SUPPL5Null15
SUPPL8Null15

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90166
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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