ANDA 203475

ACCORD HLTHCARE

FDA Drug Application

Application #203475

Application Sponsors

ANDA 203475

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-02-27
LABELING; Labeling	SUPPL	2	AP	2021-09-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-09-29	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203475
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-27
        )

)