RICONPHARMA LLC FDA Approval ANDA 211132

ANDA 211132

RICONPHARMA LLC

FDA Drug Application

Application #211132

Application Sponsors

ANDA 211132RICONPHARMA LLC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORALEQ 5MG BASE0LEUCOVORIN CALCIUMLEUCOVORIN CALCIUM
002TABLET;ORALEQ 10MG BASE0LEUCOVORIN CALCIUMLEUCOVORIN CALCIUM
003TABLET;ORALEQ 15MG BASE0LEUCOVORIN CALCIUMLEUCOVORIN CALCIUM
004TABLET;ORALEQ 25MG BASE0LEUCOVORIN CALCIUMLEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-07-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

RICONPHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211132
            [companyName] => RICONPHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-30
        )

)

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