ANDA 214504

HONG KONG

FDA Drug Application

Application #214504

Application Sponsors

ANDA 214504

HONG KONG

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/VIAL

0

MITOMYCIN

MITOMYCIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-09-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HONG KONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214504
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"MITOMYCIN","activeIngredients":"MITOMYCIN","strength":"40MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-06
        )

)