SUN PHARM INDS LTD FDA Approval ANDA 208454

ANDA 208454

SUN PHARM INDS LTD

FDA Drug Application

Application #208454

Documents

Letter2020-06-09

Application Sponsors

ANDA 208454SUN PHARM INDS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET; ORAL2.5MG/500MG0LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND METFORMIN HYDROCHLORIDE
002TABLET; ORAL2.5MG/850MG0LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND METFORMIN HYDROCHLORIDE
003TABLET; ORAL2.5MG/1GM0LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2020-05-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208454
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","strength":"2.5MG\/500MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","strength":"2.5MG\/850MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","strength":"2.5MG\/1GM","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208454Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)

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