ANDA 203732

PAR STERILE PRODUCTS

FDA Drug Application

Application #203732

Application Sponsors

ANDA 203732

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML

0

FLUPHENAZINE DECANOATE

FLUPHENAZINE DECANOATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-07-03
LABELING; Labeling	SUPPL	3	AP	2016-11-18	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-02-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AO

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203732
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUPHENAZINE DECANOATE","activeIngredients":"FLUPHENAZINE DECANOATE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/03\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/23\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/18\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-02-23
        )

)