ANDA 207052

STRIDES PHARMA

FDA Drug Application

Application #207052

Application Sponsors

ANDA 207052

STRIDES PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-05-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2017-09-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207052
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/30\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/28\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-09-28
        )

)