ANDA 206096

MYLAN LABS LTD

FDA Drug Application

Application #206096

Application Sponsors

ANDA 206096

MYLAN LABS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ATRACURIUM BESYLATE

ATRACURIUM BESYLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-07-26	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206096
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATRACURIUM BESYLATE","activeIngredients":"ATRACURIUM BESYLATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-26
        )

)