ANDA 070216

PLIVA

FDA Drug Application

Application #070216

Application Sponsors

ANDA 070216

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

800MG;160MG

0

SULFAMETHOXAZOLE AND TRIMETHOPRIM

SULFAMETHOXAZOLE; TRIMETHOPRIM

FDA Submissions

	ORIG	1	AP	1985-09-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1989-06-09
LABELING; Labeling	SUPPL	12	AP	1990-03-16
LABELING; Labeling	SUPPL	13	AP	1991-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-05-11
LABELING; Labeling	SUPPL	15	AP	1994-04-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-12-07
LABELING; Labeling	SUPPL	17	AP	1997-10-22
LABELING; Labeling	SUPPL	19	AP	1998-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2001-05-29

Submissions Property Types

ORIG	1	Null	0
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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70216
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","activeIngredients":"SULFAMETHOXAZOLE; TRIMETHOPRIM","strength":"800MG;160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SULFAMETHOXAZOLE AND TRIMETHOPRIM","submission":"SULFAMETHOXAZOLE; TRIMETHOPRIM","actionType":"800MG;160MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)