GLAND PHARMA LTD FDA Approval ANDA 207323

ANDA 207323

GLAND PHARMA LTD

FDA Drug Application

Application #207323

Application Sponsors

ANDA 207323GLAND PHARMA LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0CISPLATINCISPLATIN

FDA Submissions

UNKNOWN; ORIG1AP2017-03-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207323
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISPLATIN","activeIngredients":"CISPLATIN","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-17
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.