ANDA 208473

PRINSTON PHARMA INC

FDA Drug Application

Application #208473

Application Sponsors

ANDA 208473

PRINSTON PHARMA INC

Marketing Status

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

Application Products

002	TABLET;ORAL	2.5MG;850MG	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	2.5MG;1GM	0	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	LINAGLIPTIN; METFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-05

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)