ANDA 210212

MSN LABORATORIES PRIVATE LTD

FDA Drug Application

Application #210212

Documents

• Letter: 2019-12-04

Application Sponsors

ANDA 210212

MSN LABORATORIES PRIVATE LTD

Marketing Status

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

Application Products

001	TABLET; ORAL	12.5MG/500MG	0	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE
002	TABLET; ORAL	12.5MG/1000MG	0	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE	ALOGLIPTIN AND METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2019-11-27

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MSN LABORATORIES PRIVATE LTD

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(
    [0] => Array
        (
            [ApplNo] => 210212
            [companyName] => MSN LABORATORIES PRIVATE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALOGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN AND METFORMIN HYDROCHLORIDE","strength":"12.5MG\/500MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ALOGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"ALOGLIPTIN AND METFORMIN HYDROCHLORIDE","strength":"12.5MG\/1000MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/27\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/210212Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-27
        )

)