ANDA 207383

GLAND PHARMA LTD

FDA Drug Application

Application #207383

Application Sponsors

ANDA 207383

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

25MG/ML (25MG/ML)

0

TEMSIROLIMUS

TEMSIROLIMUS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207383
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEMSIROLIMUS","activeIngredients":"TEMSIROLIMUS","strength":"25MG\/ML (25MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-16
        )

)