ANDA 211666

STRIDES PHARMA

FDA Drug Application

Application #211666

Application Sponsors

ANDA 211666

STRIDES PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-11-09	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211666
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-22
        )

)