ANDA 208448

ZYDUS PHARMS USA INC

FDA Drug Application

Application #208448

Documents

• Letter: 2020-12-01

Application Sponsors

ANDA 208448

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

5MG

0

LINAGLIPTIN

LINAGLIPTIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-11-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208448
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINAGLIPTIN","activeIngredients":"LINAGLIPTIN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/28\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-28
        )

)