ANDA 079174

GRANULES INDIA

FDA Drug Application

Application #079174

Application Sponsors

ANDA 079174

GRANULES INDIA

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2010-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2018-04-11
LABELING; Labeling	SUPPL	14	AP	2018-04-11	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-03-23	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	10	Null	15
SUPPL	14	Null	15
SUPPL	17	Null	7

CDER Filings

GRANULES INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79174
            [companyName] => GRANULES INDIA
            [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
        )

)