LEADING PHARMA LLC FDA Approval ANDA 213929

ANDA 213929

LEADING PHARMA LLC

FDA Drug Application

Application #213929

Application Sponsors

ANDA 213929LEADING PHARMA 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; ORIG1AP2020-10-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LEADING PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213929
            [companyName] => LEADING PHARMA 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":"10\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-22
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.