ANDA 209426

TORRENT PHARMS LTD

FDA Drug Application

Application #209426

Documents

• Letter: 2019-12-10

Application Sponsors

ANDA 209426

TORRENT PHARMS LTD

Marketing Status

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

Application Products

002	TABLET, FOR SUSPENSION;ORAL	250MG	0	DEFERASIROX	DEFERASIROX
003	TABLET, FOR SUSPENSION;ORAL	500MG	0	DEFERASIROX	DEFERASIROX

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-12-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209426
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"125MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"250MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DEFERASIROX","activeIngredients":"DEFERASIROX","strength":"500MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209426Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-08
        )

)