ANDA 202471

MYLAN INSTITUTIONAL

FDA Drug Application

Application #202471

Application Sponsors

ANDA 202471

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/VIAL

0

BIVALIRUDIN

BIVALIRUDIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-06-01
LABELING; Labeling	SUPPL	3	AP	2019-09-23	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202471
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIVALIRUDIN","activeIngredients":"BIVALIRUDIN","strength":"250MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/23\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-23
        )

)