ANDA 207475

ACCORD HLTHCARE

FDA Drug Application

Application #207475

Application Sponsors

ANDA 207475

ACCORD HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS, SUBCUTANEOUS

100MG/VIAL

0

AZACITIDINE

AZACITIDINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-12-14	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	4	Null	31

TE Codes

001

Prescription

AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207475
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/02\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/22\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-22
        )

)