ANDA 206033

CHEMI SPA

FDA Drug Application

Application #206033

Application Sponsors

ANDA 206033

CHEMI SPA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-22	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-04	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AP

CDER Filings

CHEMI SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206033
            [companyName] => CHEMI SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-22
        )

)