ANDA 088921

ANI PHARMS INC

FDA Drug Application

Application #088921

Application Sponsors

ANDA 088921

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

100MG

0

CHLORPROPAMIDE

CHLORPROPAMIDE

FDA Submissions

	ORIG	1	AP	1985-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-06-17
LABELING; Labeling	SUPPL	8	AP	1988-11-17
LABELING; Labeling	SUPPL	9	AP	1991-05-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-03-24
LABELING; Labeling	SUPPL	11	AP	1992-07-29
LABELING; Labeling	SUPPL	12	AP	1993-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-05-11
LABELING; Labeling	SUPPL	14	AP	1994-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-05-29
LABELING; Labeling	SUPPL	18	AP	2001-08-09
LABELING; Labeling	SUPPL	19	AP	2003-08-04

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88921
            [companyName] => ANI PHARMS INC
            [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
        )

)