ANDA 214072

SHILPA MEDICARE LTD

FDA Drug Application

Application #214072

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 214072

SHILPA MEDICARE LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

25MG

0

TENOFOVIR ALAFENAMIDE

TENOFOVIR ALAFENAMIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-09-15

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SHILPA MEDICARE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214072
            [companyName] => SHILPA MEDICARE LTD
            [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":"09\/15\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-15
        )

)