ANDA 070736

AUROLIFE PHARMA LLC

FDA Drug Application

Application #070736

Application Sponsors

ANDA 070736

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	600MG	0	IBUPROFEN	IBUPROFEN
002	TABLET;ORAL	300MG	0	IBUPROFEN	IBUPROFEN
003	TABLET;ORAL	400MG	0	IBUPROFEN	IBUPROFEN

FDA Submissions

	ORIG	1	AP	1986-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-04-06
LABELING; Labeling	SUPPL	8	AP	1988-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-05-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-06-29
LABELING; Labeling	SUPPL	11	AP	1988-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1989-03-01
LABELING; Labeling	SUPPL	14	AP	1989-01-19
LABELING; Labeling	SUPPL	16	AP	1989-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-01-28
LABELING; Labeling	SUPPL	20	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70736
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)