ZYDUS NOVELTECH INC FDA Approval ANDA 206318

ANDA 206318

ZYDUS NOVELTECH INC

FDA Drug Application

Application #206318

Application Sponsors

ANDA 206318ZYDUS NOVELTECH INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL4.6MG/24HR0RIVASTIGMINERIVASTIGMINE
002FILM, EXTENDED RELEASE;TRANSDERMAL9.5MG/24HR0RIVASTIGMINERIVASTIGMINE
003FILM, EXTENDED RELEASE;TRANSDERMAL13.3MG/24HR0RIVASTIGMINERIVASTIGMINE

FDA Submissions

UNKNOWN; ORIG1AP2019-03-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206318
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"4.6MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"9.5MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIVASTIGMINE","activeIngredients":"RIVASTIGMINE","strength":"13.3MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-04
        )

)

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