ANDA 210892

GLAND PHARMA LTD

FDA Drug Application

Application #210892

Documents

• Letter: 2018-06-05

Application Sponsors

ANDA 210892

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM
002	SOLUTION;INTRAVENOUS	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-09-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210892
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 250MG BASE\/25ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210892Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-14
        )

)