MAYNE PHARMA INC FDA Approval ANDA 207270

ANDA 207270

MAYNE PHARMA INC

FDA Drug Application

Application #207270

Application Sponsors

ANDA 207270MAYNE PHARMA INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL15MG0MORPHINE SULFATEMORPHINE SULFATE
002TABLET;ORAL30MG0MORPHINE SULFATEMORPHINE SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-02STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MAYNE PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207270
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-02
        )

)

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