ANDA 209535

MACLEODS PHARMS LTD

FDA Drug Application

Application #209535

Application Sponsors

ANDA 209535

MACLEODS PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CREAM;TOPICAL	0.025%	0	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE
002	CREAM;TOPICAL	0.1%	0	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE
003	CREAM;TOPICAL	0.5%	0	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2022-11-08	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	12	Null	7

TE Codes

001	Prescription	AT
002	Prescription	AT
003	Prescription	AT

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209535
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.025%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)