ANDA 212795

TENSHI

FDA Drug Application

Application #212795

Documents

• Letter: 2020-10-30

Application Sponsors

ANDA 212795

TENSHI

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET, ORALLY DISINTEGRATING;ORAL

5MG

0

LORATADINE

LORATADINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-09-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

TENSHI

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212795
            [companyName] => TENSHI
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORATADINE","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-18
        )

)