ANDA 085844

AUROLIFE PHARMA LLC

FDA Drug Application

Application #085844

Application Sponsors

ANDA 085844

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

SULFAMETHOXAZOLE

SULFAMETHOXAZOLE

FDA Submissions

	ORIG	1	AP	1978-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1982-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1983-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1983-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1983-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1983-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1984-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1984-05-11

Submissions Property Types

SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85844
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE","activeIngredients":"SULFAMETHOXAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE","submission":"SULFAMETHOXAZOLE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)