ANDA 204607

PHARMASCIENCE INC

FDA Drug Application

Application #204607

Application Sponsors

ANDA 204607

PHARMASCIENCE INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-31
LABELING; Labeling	SUPPL	3	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

PHARMASCIENCE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204607
            [companyName] => PHARMASCIENCE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-31
        )

)