ANDA 040039

TARO PHARM INDS LTD

FDA Drug Application

Application #040039

Application Sponsors

ANDA 040039

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1997-11-26
LABELING; Labeling	SUPPL	3	AP	2005-06-15
LABELING; Labeling	SUPPL	17	AP	2019-11-27	STANDARD

Submissions Property Types

SUPPL

17

Null

7

TE Codes

001

Prescription

AT

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40039
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)