ANDA 213929

LEADING PHARMA LLC

FDA Drug Application

Application #213929

Application Sponsors

ANDA 213929

LEADING PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
002	TABLET;ORAL	EQ 10MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
003	TABLET;ORAL	EQ 15MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM
004	TABLET;ORAL	EQ 25MG BASE	0	LEUCOVORIN CALCIUM	LEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

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
        )

)