ANDA 208485

HONG KONG

FDA Drug Application

Application #208485

Application Sponsors

ANDA 208485

HONG KONG

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

CYTARABINE

CYTARABINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HONG KONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208485
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYTARABINE","activeIngredients":"CYTARABINE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-28
        )

)