ANDA 091237

MARKSANS PHARMA

FDA Drug Application

Application #091237

Application Sponsors

ANDA 091237

MARKSANS PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2011-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2016-02-08	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

MARKSANS PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91237
            [companyName] => MARKSANS 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":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)