ANDA 090166

SANDOZ INC

FDA Drug Application

Application #090166

Documents

• Letter: 2009-06-02

Application Sponsors

ANDA 090166

SANDOZ INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	2009-05-27
LABELING; Labeling	SUPPL	2	AP	2011-03-28
LABELING; Labeling	SUPPL	5	AP	2012-11-13	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-10-22	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	15
SUPPL	8	Null	15

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
        )

)