ANDA 209697

TORRENT PHARMA INC

FDA Drug Application

Application #209697

Documents

• Letter: 2019-02-21

Application Sponsors

ANDA 209697

TORRENT PHARMA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	7MG	0	TERIFLUNOMIDE	TERIFLUNOMIDE
002	TABLET;ORAL	14MG	0	TERIFLUNOMIDE	TERIFLUNOMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TORRENT PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209697
            [companyName] => TORRENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/02\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209697Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-02
        )

)