ANDA 215834

LOTUS PHARM CO LTD

FDA Drug Application

Application #215834

Documents

• Letter: 2022-09-07

Application Sponsors

ANDA 215834

LOTUS PHARM CO LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

CAPSULE;ORAL

25MG

0

MIDOSTAURIN

MIDOSTAURIN

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-08-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LOTUS PHARM CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215834
            [companyName] => LOTUS PHARM CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDOSTAURIN","activeIngredients":"MIDOSTAURIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)