ANDA 208860

MYLAN LABS LTD

FDA Drug Application

Application #208860

Application Sponsors

ANDA 208860

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

20MG/20ML (1MG/ML)

0

CLOFARABINE

CLOFARABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-05-19	STANDARD
LABELING; Labeling	SUPPL	7	AP	2023-01-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	7	Null	7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208860
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOFARABINE","activeIngredients":"CLOFARABINE","strength":"20MG\/20ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-06
        )

)