ANDA 207385

GLAND PHARMA LTD

FDA Drug Application

Application #207385

Application Sponsors

ANDA 207385

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INTRAVENOUS	50MG/VIAL	0	OXALIPLATIN	OXALIPLATIN
002	INJECTABLE;INTRAVENOUS	100MG/VIAL	0	OXALIPLATIN	OXALIPLATIN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207385
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-23
        )

)