ANDA 088164

ANI PHARMS INC

FDA Drug Application

Application #088164

Application Sponsors

ANDA 088164

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

CHLORTHALIDONE

CHLORTHALIDONE

FDA Submissions

	ORIG	1	AP	1984-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-09-17
LABELING; Labeling	SUPPL	8	AP	1993-03-08
LABELING; Labeling	SUPPL	9	AP	1995-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-07-29

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88164
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORTHALIDONE","activeIngredients":"CHLORTHALIDONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORTHALIDONE","submission":"CHLORTHALIDONE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)