ANDA 215037

ZYDUS PHARMS

FDA Drug Application

Application #215037

Application Sponsors

ANDA 215037

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

250MG/50ML (5MG/ML)

0

NELARABINE

NELARABINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215037
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NELARABINE","activeIngredients":"NELARABINE","strength":"250MG\/50ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-17
        )

)