ANDA 090796

MARKSANS PHARMA

FDA Drug Application

Application #090796

Application Sponsors

ANDA 090796

MARKSANS PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	400MG	0	IBUPROFEN	IBUPROFEN
002	TABLET;ORAL	600MG	0	IBUPROFEN	IBUPROFEN
003	TABLET;ORAL	800MG	0	IBUPROFEN	IBUPROFEN

FDA Submissions

	ORIG	1	AP	2010-12-21
LABELING; Labeling	SUPPL	2	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	31

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MARKSANS PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90796
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)