ANDA 214226

LUPIN PHARMS

FDA Drug Application

Application #214226

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 214226

LUPIN PHARMS

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214226
            [companyName] => LUPIN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENOFOVIR ALAFENAMIDE","activeIngredients":"TENOFOVIR ALAFENAMIDE","strength":"25mg","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/14\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-14
        )

)