ANDA 212960

HONG KONG

FDA Drug Application

Application #212960

Application Sponsors

ANDA 212960

HONG KONG

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HONG KONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212960
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN HYDROCHLORIDE","activeIngredients":"MELPHALAN HYDROCHLORIDE","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-28
        )

)