LUPIN ATLANTIS FDA Approval ANDA 208763

ANDA 208763

LUPIN ATLANTIS

FDA Drug Application

Application #208763

Application Sponsors

ANDA 208763LUPIN ATLANTIS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CREAM;TOPICAL0.025%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE
002CREAM;TOPICAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE
003CREAM;TOPICAL0.5%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-02-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAT
002PrescriptionAT
003PrescriptionAT

CDER Filings

LUPIN ATLANTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208763
            [companyName] => LUPIN ATLANTIS
            [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":"02\/01\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-01
        )

)

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