ANDA 204949

MYLAN INSTITUTIONAL

FDA Drug Application

Application #204949

Application Sponsors

ANDA 204949

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS, SUBCUTANEOUS

100MG/VIAL

0

AZACITIDINE

AZACITIDINE

FDA Submissions

LABELING; Labeling	ORIG	1	AP	2016-04-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-02-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-02-12	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	7
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204949
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Labeling","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-12
        )

)