ANDA 088725

AUROLIFE PHARMA LLC

FDA Drug Application

Application #088725

Application Sponsors

ANDA 088725

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

CHLORPROPAMIDE

CHLORPROPAMIDE

FDA Submissions

	ORIG	1	AP	1984-08-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-01-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-12-30
BIOEQUIV; Bioequivalence	SUPPL	15	AP	1989-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1999-12-14

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88725
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)