RICONPHARMA LLC FDA Approval ANDA 215584

ANDA 215584

RICONPHARMA LLC

FDA Drug Application

Application #215584

Application Sponsors

ANDA 215584RICONPHARMA LLC

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-02-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

RICONPHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215584
            [companyName] => RICONPHARMA LLC
            [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":"02\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-07
        )

)

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