ANDA 203800

MYLAN LABS LTD

FDA Drug Application

Application #203800

Application Sponsors

ANDA 203800

MYLAN LABS LTD

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 100MG BASE/VIAL	0	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM
002	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	0	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM
003	INJECTABLE;INJECTION	EQ 350MG BASE/VIAL	0	LEUCOVORIN CALCIUM PRESERVATIVE FREE	LEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-19

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203800
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 200MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEUCOVORIN CALCIUM PRESERVATIVE FREE","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 350MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-19
        )

)