ANDA 209932

MYLAN LABS LTD

FDA Drug Application

Application #209932

Application Sponsors

ANDA 209932

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1GM/100ML

0

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

MAGNESIUM SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-09-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-11-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209932
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"MAGNESIUM SULFATE","strength":"1GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-27
        )

)