ANDA 207651

ALKEM LABS LTD

FDA Drug Application

Application #207651

Application Sponsors

ANDA 207651

ALKEM LABS 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

2017-12-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AT
002	Prescription	AT
003	Prescription	AT

CDER Filings

ALKEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207651
            [companyName] => ALKEM LABS 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":"12\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-26
        )

)