ANDA 040037

TARO PHARM INDS LTD

FDA Drug Application

Application #040037

Application Sponsors

ANDA 040037

TARO PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.1%

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

	ORIG	1	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-09-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-11-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2016-10-26	UNKNOWN

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	16	Null	7

TE Codes

001

Prescription

AT

CDER Filings

TARO PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40037
            [companyName] => TARO PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)