ANDA 215059

GLAND PHARMA LTD

FDA Drug Application

Application #215059

Application Sponsors

ANDA 215059

GLAND PHARMA LTD

Marketing Status

• None (Tentative Approval): 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	2MG/ML	0	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE
002	INJECTABLE;INJECTION	1MG/ML	0	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215059
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-19
        )

)