ANDA 210763

MYLAN LABS LTD

FDA Drug Application

Application #210763

Application Sponsors

ANDA 210763

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML

0

SODIUM NITROPRUSSIDE

SODIUM NITROPRUSSIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210763
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM NITROPRUSSIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/11\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-11
        )

)