ANDA 087706

ANI PHARMS INC

FDA Drug Application

Application #087706

Application Sponsors

ANDA 087706

ANI PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

CHLORTHALIDONE

CHLORTHALIDONE

FDA Submissions

	ORIG	1	AP	1981-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1985-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1985-08-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-04-13
LABELING; Labeling	SUPPL	13	AP	1989-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1991-01-28
LABELING; Labeling	SUPPL	17	AP	1994-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-09-14

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87706
            [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
        )

)