ANDA 200888

STRIDES PHARMA

FDA Drug Application

Application #200888

Application Sponsors

ANDA 200888

STRIDES PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2016-12-28	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200888
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN","strength":"25MG;EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/28\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-12-28
        )

)