ANDA 211549

AMNEAL

FDA Drug Application

Application #211549

Application Sponsors

ANDA 211549

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS, SUBCUTANEOUS

100MG/VIAL

0

AZACITIDINE

AZACITIDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211549
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZACITIDINE","activeIngredients":"AZACITIDINE","strength":"100MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)