ANDA 087547

ALCON

FDA Drug Application

Application #087547

Application Sponsors

ANDA 087547

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;OPHTHALMIC

0.25%;10%

0

ISOPTO CETAPRED

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1981-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-04-27
LABELING; Labeling	SUPPL	6	AP	1989-10-26
LABELING; Labeling	SUPPL	7	AP	1990-12-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-06-04
LABELING; Labeling	SUPPL	9	AP	1993-01-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-06-04
LABELING; Labeling	SUPPL	11	AP	1993-04-28
LABELING; Labeling	SUPPL	12	AP	1993-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-06-28
LABELING; Labeling	SUPPL	14	AP	1994-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1995-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1995-10-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1996-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1996-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-04-28

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87547
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPTO CETAPRED","activeIngredients":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","strength":"0.25%;10%","dosageForm":"SUSPENSION;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOPTO CETAPRED","submission":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","actionType":"0.25%;10%","submissionClassification":"SUSPENSION;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)