ANDA 210160

TORRENT PHARMS LTD

FDA Drug Application

Application #210160

Documents

• Letter: 2019-01-18

Application Sponsors

ANDA 210160

TORRENT PHARMS LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 12.5MG BASE;500MG	0	ALOGLIPTIN; METFORMIN HYDROCHLORIDE	ALOGLIPTIN; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	EQ 12.5MG BASE;1GM	0	ALOGLIPTIN; METFORMIN HYDROCHLORIDE	ALOGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

TORRENT PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210160
            [companyName] => TORRENT PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"EQ 12.5MG BASE;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN; METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"EQ 12.5MG BASE;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210160Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-19
        )

)