ANDA 214071

STRIDES PHARMA

FDA Drug Application

Application #214071

Documents

• Letter: 2022-08-01

Application Sponsors

ANDA 214071

STRIDES PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION/DROPS;ORAL

50MG/1.25ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214071
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"50MG\/1.25ML","dosageForm":"SUSPENSION\/DROPS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-09
        )

)