ANDA 212034

ACCORD HLTHCARE

FDA Drug Application

Application #212034

Application Sponsors

ANDA 212034

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

20MG/20ML (1MG/ML)

0

CLOFARABINE

CLOFARABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212034
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOFARABINE","activeIngredients":"CLOFARABINE","strength":"20MG\/20ML (1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-22
        )

)