ANDA 204469

STRIDES PHARMA

FDA Drug Application

Application #204469

Application Sponsors

ANDA 204469

STRIDES PHARMA

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2020-04-06

Submissions Property Types

ORIG	1	Null	17
SUPPL	3	Null	15

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204469
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-06
        )

)