ANDA 215584

RICONPHARMA LLC

FDA Drug Application

Application #215584

Application Sponsors

ANDA 215584

RICONPHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	15MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

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
        )

)