ANDA 209826

GLAND PHARMA LTD

FDA Drug Application

Application #209826

Application Sponsors

ANDA 209826

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-28

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209826
            [companyName] => GLAND PHARMA LTD
            [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\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-28
        )

)