PRINSTON PHARMA INC FDA Approval ANDA 208473

ANDA 208473

PRINSTON PHARMA INC

FDA Drug Application

Application #208473

Application Sponsors

ANDA 208473PRINSTON PHARMA INC

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN; ORIG1TA2022-04-05STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208473
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;850MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LINAGLIPTIN AND METFORMIN HYDROCHLORIDE","activeIngredients":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","strength":"2.5MG;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/05\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-05
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.