ANDA 210159

TORRENT PHARMA INC

FDA Drug Application

Application #210159

Documents

• Letter: 2019-01-18

Application Sponsors

ANDA 210159

TORRENT PHARMA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TORRENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210159
            [companyName] => TORRENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN","strength":"6.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-12
        )

)