ANDA 203576

MYLAN TEORANTA

FDA Drug Application

Application #203576

Documents

• Letter: 2015-10-22

Application Sponsors

ANDA 203576

MYLAN TEORANTA

Marketing Status

• Discontinued: 001
• Discontinued: 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

2015-10-20

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MYLAN TEORANTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203576
            [companyName] => MYLAN TEORANTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 250MG BASE\/25ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203576Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/06\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-06
        )

)