ANDA 090164

SANDOZ INC

FDA Drug Application

Application #090164

Documents

• Letter: 2009-06-02
• Review: 2012-11-16

Application Sponsors

ANDA 090164

SANDOZ INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

40MG/ML

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	2009-06-01
LABELING; Labeling	SUPPL	3	AP	2011-03-18
LABELING; Labeling	SUPPL	6	AP	2012-11-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	6	Null	15
SUPPL	9	Null	15

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90164
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)