DIPHARMA FDA Approval ANDA 212390

ANDA 212390

DIPHARMA

FDA Drug Application

Application #212390

Application Sponsors

ANDA 212390DIPHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORAL2MG0NITISINONENITISINONE
002CAPSULE;ORAL5MG0NITISINONENITISINONE
003CAPSULE;ORAL10MG0NITISINONENITISINONE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

DIPHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212390
            [companyName] => DIPHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NITISINONE","activeIngredients":"NITISINONE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)

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