ANDA 214003

YICHANG HUMANWELL

FDA Drug Application

Application #214003

Application Sponsors

ANDA 214003

YICHANG HUMANWELL

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

YICHANG HUMANWELL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214003
            [companyName] => YICHANG HUMANWELL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/21\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-21
        )

)