ANDA 210213

MSN LABS PVT LTD

FDA Drug Application

Application #210213

Documents

• Letter: 2019-02-21

Application Sponsors

ANDA 210213

MSN LABS PVT LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 6.25MG BASE	0	ALOGLIPTIN	ALOGLIPTIN BENZOATE
002	TABLET;ORAL	EQ 12.5MG BASE	0	ALOGLIPTIN	ALOGLIPTIN BENZOATE
003	TABLET;ORAL	EQ 25MG BASE	0	ALOGLIPTIN	ALOGLIPTIN BENZOATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-01-29

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABS PVT LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210213
            [companyName] => MSN LABS PVT LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 6.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/29\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210213Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-29
        )

)