ANDA 079205

MARKSANS PHARMA

FDA Drug Application

Application #079205

Documents

• Review: 2011-09-19

Application Sponsors

ANDA 079205

MARKSANS PHARMA

Marketing Status

• Over-the-counter: 001

Application Products

001

CAPSULE;ORAL

EQ 200MG FREE ACID AND POTASSIUM SALT

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2009-06-26
LABELING; Labeling	SUPPL	2	AP	2013-07-31
LABELING; Labeling	SUPPL	4	AP	2015-04-10

Submissions Property Types

SUPPL	2	Null	8
SUPPL	4	Null	7

CDER Filings

MARKSANS PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79205
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"EQ 200MG FREE ACID AND POTASSIUM SALT","dosageForm":"CAPSULE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"EQ 200MG FREE ACID AND POTASSIUM SALT","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)